FDA 510(k) / PMA Clearance Monitor

One event per new FDA device decision: 510(k) clearances and PMA approvals and supplements, filtered by the product codes, applicants, device keywords or review panels you watch. Built for medtech RA, product and competitive-intelligence teams who need "tell me when a competitor or my product code gets cleared", not a database dump.

Pricing: pay per event. clearance-matched — one event per decision returned. Zero matches costs you nothing.

A filter is required: at least one of product codes, applicants, device keywords or advisory committees. Different filter fields combine with AND (a Medtronic decision under product code DQY); entries within one field combine with OR. PMA "30-Day Notice" supplements (routine manufacturing-change notices, most PMA decisions in a typical year) are skipped unless you turn that off.

Input

{"sources": "both", "applicants": ["medtronic", "boston scientific"],
 "product_codes": ["DQY", "QYI"], "since_days": 30}

Run it on a schedule: with Only decisions not seen before on (the default), each decision is returned and charged once per watch, even when windows overlap. FDA decisions reach openFDA days to weeks after the decision date (openFDA updates these datasets about monthly), so keep the window at 30 days or more.

Example output (one dataset item per decision)

{"source": "510k", "decision_id": "K262526", "submission_number": "K262526",
 "supplement_number": null, "decision_date": "2026-09-13",
 "date_received": "2026-07-22", "decision_code": "SESE",
 "decision_description": "Substantially Equivalent",
 "applicant": "Tianjin Huahong Technology Co., Ltd.",
 "device_name": "Safety lancet (XL)",
 "generic_name": "Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature",
 "product_code": "FMK", "device_class": "2", "regulation_number": "878.4850",
 "advisory_committee": "SU", "advisory_committee_description": "General, Plastic Surgery",
 "submission_type": "Traditional", "supplement_reason": null, "summary": "Summary",
 "applicant_state": null, "applicant_country": "CN",
 "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262526"}

A PMA supplement looks like this (abridged):

{"source": "pma", "decision_id": "P220026S014", "supplement_number": "S014",
 "decision_date": "2026-09-10", "decision_code": "APPR",
 "applicant": "Medtronic, Inc.", "generic_name": "Ablation catheter, renal denervation",
 "product_code": "QYI", "device_class": "3",
 "submission_type": "Normal 180 Day Track No User Fee",
 "supplement_reason": "Labeling Change - PAS",
 "fda_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220026S014"}

Output fields

One dataset item per result; every field is always present (empty or null when the source has no value). Defined in .actor/dataset_schema.json.

Field	Type	Description
source	string	510k or pma
decision_id	string	K-number, or PMA number + supplement number (e.g. P150031S084)
submission_number	string	510(k) K-number or PMA number
supplement_number	string or null	PMA supplement number (null for 510(k) and original PMAs)
decision_date	string or null	FDA decision date, YYYY-MM-DD
date_received	string or null	Date FDA received the submission, YYYY-MM-DD
decision_code	string or null	FDA decision code (e.g. SESE, APPR)
decision_description	string or null	Decision description (510(k) only; e.g. Substantially Equivalent)
applicant	string or null	Applicant (company)
device_name	string or null	510(k) device name or PMA trade name
generic_name	string or null	PMA generic name, or the 510(k) product code's classification name
product_code	string or null	FDA product code
device_class	string or null	Device class (1, 2, 3) from the product classification
regulation_number	string or null	21 CFR regulation number
advisory_committee	string or null	Review panel code
advisory_committee_description	string or null	Review panel name
submission_type	string or null	510(k) clearance type (Traditional, Special, ...) or PMA supplement type
supplement_reason	string or null	PMA supplement reason
summary	string or null	PMA approval-order statement (max 500 chars), or 510(k) Summary/Statement flag
applicant_state	string or null	Applicant's US state
applicant_country	string or null	Applicant's country code (510(k) only)
fda_url	string	FDA database page for this decision

Runs stop cleanly at your max-charge limit: nothing is pushed past what you agreed to pay for.

Source: openFDA device 510(k) and PMA APIs (public, CC0). Without a key openFDA allows 1,000 requests per day per IP address, and Apify IPs are shared, so heavy schedules should add a free openFDA API key. openFDA's disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated." This Actor is not affiliated with or endorsed by the FDA. Also see the FDA Recall Monitor for device, drug and food recalls.