You can access the FDA 510(k) Clearance Tracker programmatically from your own applications by using the Apify API. You can also choose the language preference from below. To use the Apify API, you’ll need an Apify account and your API token, found in API & Integrations in Apify Console.

Python

JavaScript

CLI

OpenAPI

HTTP

MCP

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  "components": {
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          "sourceMode": {
            "title": "FDA clearance source",
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            ],
            "type": "string",
            "description": "Live is the normal default and reads the official openFDA Device 510(k) API. Captured fixture is only for deterministic package verification. Sample remains a legacy saved-task alias and is not the Store default.",
            "default": "live"
          },
          "mode": {
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              "watchlist",
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            ],
            "type": "string",
            "description": "Normal uses the live official API. Demo is retained only for saved tasks and maps to the captured verification fixture.",
            "default": "normal"
          },
          "startUrls": {
            "title": "Official FDA API URL",
            "type": "array",
            "description": "Optional compatibility override. Only https://api.fda.gov/device/510k.json is accepted; other URLs are ignored.",
            "default": [
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                "url": "https://api.fda.gov/device/510k.json",
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              }
            ],
            "items": {
              "type": "object",
              "required": [
                "url"
              ],
              "properties": {
                "url": {
                  "type": "string",
                  "title": "URL of a web page",
                  "format": "uri"
                }
              }
            }
          },
          "maxItems": {
            "title": "Maximum clearance records",
            "minimum": 1,
            "maximum": 10,
            "type": "integer",
            "description": "Maximum matching FDA 510(k) records to emit. The Store default is one live result to keep unattended runs bounded.",
            "default": 1
          },
          "applicantNames": {
            "title": "Applicant filters",
            "type": "array",
            "description": "Optional case-insensitive applicant filters. Leave empty to return the newest eligible clearance.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "productCodes": {
            "title": "FDA product-code filters",
            "type": "array",
            "description": "Optional case-insensitive FDA product-code filters. Leave empty to return the newest eligible clearance.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "advisoryCommittees": {
            "title": "FDA advisory-committee filters",
            "type": "array",
            "description": "Optional case-insensitive advisory-committee filters. Leave empty to return the newest eligible clearance.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "sinceLastRun": {
            "title": "Only newly seen clearances",
            "type": "boolean",
            "description": "When enabled, stores seen FDA K numbers under the state key and emits only newly observed matching clearances.",
            "default": false
          },
          "stateKey": {
            "title": "Clearance delta state key",
            "type": "string",
            "description": "Optional storage key for this Actor's FDA 510(k) delta state.",
            "default": "FDA_510K_CLEARANCES_SEEN"
          },
          "watchlistTerms": {
            "title": "Legacy keyword filters",
            "type": "array",
            "description": "Compatibility alias for saved tasks. Values are applied to K number, device, applicant, product code, and committee fields.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "lookbackDays": {
            "title": "Legacy lookback window",
            "minimum": 1,
            "maximum": 3650,
            "type": "integer",
            "description": "Compatibility setting for existing tasks. The public API query remains ordered by clearance decision date.",
            "default": 30
          },
          "baselineDatasetId": {
            "title": "Legacy baseline dataset ID",
            "type": "string",
            "description": "Compatibility setting retained for saved tasks; this Actor's official API delta state uses K numbers."
          },
          "sourceIds": {
            "title": "Legacy source IDs",
            "type": "array",
            "description": "Compatibility setting retained for saved tasks. The official source ID is OPENFDA-DEVICE-510-K-API.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "pricingEvents": {
            "title": "Legacy pricing-event selector",
            "type": "array",
            "description": "Compatibility setting retained for saved tasks. Live delivered records use the existing result-delivered event configuration.",
            "default": [],
            "items": {
              "type": "string"
            }
          },
          "includeSourceUrls": {
            "title": "Include source URLs",
            "type": "boolean",
            "description": "Compatibility setting. FDA source URLs remain part of every output record for provenance.",
            "default": true
          },
          "includeMatchReasons": {
            "title": "Include match reasons",
            "type": "boolean",
            "description": "Compatibility setting. Each output record includes its official-source match reason.",
            "default": true
          },
          "includeRaw": {
            "title": "Include raw source fragments",
            "type": "boolean",
            "description": "Compatibility setting. Raw provider fragments are not emitted by default.",
            "default": false
          },
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            "title": "Legacy diagnostic setting",
            "type": "boolean",
            "description": "Compatibility setting. A failed official API read fails transparently; no synthetic diagnostic record is emitted.",
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          },
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              "buyer-ready-records",
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            ],
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            "default": "buyer-ready-records"
          },
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            "title": "Completion webhook URL",
            "type": "string",
            "description": "Optional endpoint that receives a compact completion summary after a run."
          },
          "actorSlug": {
            "title": "Actor slug",
            "type": "string",
            "description": "Compatibility traceability field for saved tasks."
          }
        }
      },
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        "properties": {
          "data": {
            "type": "object",
            "properties": {
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              },
              "actId": {
                "type": "string"
              },
              "userId": {
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              },
              "startedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "finishedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "status": {
                "type": "string",
                "example": "READY"
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              "meta": {
                "type": "object",
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                  "origin": {
                    "type": "string",
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                  "userAgent": {
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              "stats": {
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                    "type": "integer",
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                  "rebootCount": {
                    "type": "integer",
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                  "restartCount": {
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                  },
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                    "example": 1024
                  },
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              },
              "buildId": {
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              "defaultKeyValueStoreId": {
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              "defaultDatasetId": {
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              },
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                "example": "1.0.0"
              },
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              },
              "usage": {
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                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
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                  },
                  "DATASET_WRITES": {
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                  },
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                    "example": 1
                  },
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}

FDA 510(k) clearances — openFDA OpenAPI definition

OpenAPI is a standard for designing and describing RESTful APIs, allowing developers to define API structure, endpoints, and data formats in a machine-readable way. It simplifies API development, integration, and documentation.

OpenAPI is effective when used with AI agents and GPTs by standardizing how these systems interact with various APIs, for reliable integrations and efficient communication.

By defining machine-readable API specifications, OpenAPI allows AI models like GPTs to understand and use varied data sources, improving accuracy. This accelerates development, reduces errors, and provides context-aware responses, making OpenAPI a core component for AI applications.

You can download the OpenAPI definitions for FDA 510(k) Clearance Tracker from the options below:

OpenAPI.json

If you’d like to learn more about how OpenAPI powers GPTs, read our blog post.

You can also check out our other API clients:

FDA 510(k) Clearance Tracker API in Python

FDA 510(k) Clearance Tracker API in JavaScript

FDA 510(k) Clearance Tracker API through CLI

FDA 510(k) Clearance Tracker API

FDA 510k Device Clearance Monitor

technicaldost/fda-device-510k-monitor

Track recent medical device 510(k) clearances from openFDA.

Technical Dost Solutions

FDA 510(k) Device Clearance Landscape

taroyamada/fda-510k-device-clearance-landscape-report

Try for free → Input → Start (1 FDA 510(k) row ≈ USD 0.004/row). FDA 510(k) device clearance landscape report for competitive and regulatory monitoring. Paste device terms. From USD 4/1k.

naoki anzai

FDA Device Clearance Records — 510(k) via openFDA

nexgensignal/fda-device-clearance-records

Per-record FDA 510(k) medical-device clearances from the official openFDA API. Applicant, device, product code, decision, dates, class. Keyless, public domain, no personal data.

NexGen Signal

FDA 510(k) Scraper - Medical Device Clearance API

pink_comic/fda-510k-medical-device-clearances

Search FDA 510(k) medical device clearances via the official OpenFDA API. Use this scraper/API to find cleared devices by name, applicant, product code, or decision date and monitor competitor approvals, regulatory decisions, and predicate devices. No FDA API key needed.

Ava Torres

FDA 510(k) Device Clearances Scraper

nexgenwatch/fda-510k-device-clearances

Clean, structured records of medical-device 510(k) clearances, sourced live from the official openFDA device 510(k) API (https://api.fda.gov/device/510k.json) — an anonymous, documented U.S. Food & Drug Administration endpoint.

NexGen Watch

🩺 FDA 510(k) Clearance Competitive Intelligence

snuggly_beanie_970/fda-510k-clearance-competitive-intelligence

Find new FDA 510(k) clearances with applicant, product-code classification, review duration, regulatory flags, competitive activity counts and official evidence links.

Ilia

FDA 510(k) / PMA Clearance Monitor (medical devices)

sovereign_workspace/fda-510k-pma-monitor

Watch openFDA 510(k) and PMA clearances filtered by product code, applicant, panel, or keywords. Charges once per matched clearance; only-new mode skips repeats.

Chase Mariano

FDA 510(k) MedTech Device Clearance & Regulatory Radar

robinworld/fda-medtech-device-clearance-tracker

Instant openFDA radar tracking 510(k) clearances, medical device PMA approvals, and biotech commercialization alerts.

Robin world

FDA 510(k) Premarket Clearances Scraper

scrapers_lat/fda-510k-clearances-scraper

Scrape FDA 510(k) premarket clearances from the official openFDA database. Filter by device, applicant, product code, medical specialty, state, country, clearance type and decision date. Enrich with device class and regulation. Export JSON, CSV, Excel.

Scrapers Lat

FDA 510(k) Device Clearance Search

maximedupre/fda-510k

Search official FDA 510(k) clearances and save structured device, applicant, decision, classification, review, and source data. You can also rank matching clearances by applicant, year, device class, or product code.