FDA 510(k) Newly Cleared Medical Device Go-To-Market Leads

NEWAPI25 | newapi25-fda-510k-device-clearances | v0.1.0

Find recent FDA substantially equivalent (SE) 510(k) decisions in the official, public openFDA Device 510(k) Clearances dataset. Output one official applicant/manufacturer-of-record lead for each unique k_number, including publicly listed applicant correspondent and business mailing address when present. These are evidence-backed market-intelligence records, not verified purchasers, distributors, live sales channels or indications of actual product launch.

Source, meaning and update cadence

• Official source: openFDA Device 510(k) API. The API dataset is refreshed monthly (the FDA's separate source/releasable 510(k) website may have another posting cadence).
• decision_date is the FDA's decision date, not the data ingestion date. observed_at is UTC when this Actor saw the record. The run summary also saves apiLastUpdated from the FDA response metadata.
• Cleared decisions are restricted to FDA decision_code in SESE, SEKD, SESD, SESK, SESP, SESU, optionally checked against a Substantially Equivalent decision description. Negative / pending / revoked / recall-like codes (including SESR) are excluded. De Novo IDs beginning with DEN are excluded. A received submission or a non-substantial-equivalence finding is not a clearance.
• 510(k) substantial equivalence is not PMA approval, a claim that a device is safe for every use, evidence of sales, evidence of distribution, or proof of market launch.
• applicant_company is the FDA applicant, not necessarily the final seller, marketer or distributor. The contact_person is the FDA-published applicant correspondent (when available), not a preverified sales contact.
• device_class uses the FDA's directly harmonized openfda.device_class if present. Missing classes trigger a verified /device/classification.json product-code lookup. If multiple contradictory classes exist for a product code or no matching class exists, it remains null. A current product-code classification is not necessarily the historical classification on the decision date.
• Specialty input filters the historical FDA advisory_committee panel. This can differ from today's review_advisory_committee; output prefers the FDA harmonized regulatory specialty when it exists. Country/state/business addresses reflect public FDA applicant business fields.

Inputs

Field	Meaning
decisionDateFrom, decisionDateTo	Inclusive ISO dates. Omitted = past 60 days to today's UTC date.
medicalSpecialty	FDA panel abbreviation, e.g. CV (cardiovascular), RA (radiology).
productCode	Three-letter FDA product code, e.g. DRF or QAS.
deviceNameKeyword	Phrase search on official device name.
applicantCompany	Phrase search on FDA applicant field.
maxResults	Hard limit on unique emitted k_number (default 10).
maxCostUsd	Input cost ceiling for per-result events at $0.007 (default $0.07).
pageSize / maxApiRequests	Operational limits (defaults 100/30).
resume	Resume from same-run checkpoint and dataset IDs (default true).
fdaApiKey	Optional encrypted input; alternatively set OPENFDA_API_KEY runtime env.

Default input emits up to 10 results and finishes quickly in ordinary network conditions; no result is fabricated when none matches. Multiple broad filters require pagination and can take longer.

Outputs

Each dataset row has exactly these 12 fields: k_number, device_name, applicant_company, contact_person, business_address, decision_date, decision_code, medical_specialty, device_class, product_code, source_url, observed_at.

The default Apify Dataset is downloadable as JSON or CSV using the Dataset export UI or GET /v2/datasets/:datasetId/items?format=json|csv. A NEWAPI25_RUN_SUMMARY record in the run's default key-value store shows metadata and counters. Only 510(k) clearance rows are emitted; missing optional contact/class fields are null, never guessed.

FDA API and responsible API access

• URL: https://api.fda.gov/device/510k.json. Maximum limit 1000 per request; maximum skip 25000. This Actor rejects deeper offsets. For records beyond that bound, narrow decision date/product/specialty filters and rerun.
• openFDA currently documents 240 requests/minute and 1,000 requests/day/IP without a key, or 240 requests/minute/key and 120,000 requests/day/key with a free key. No proxy or key bypass is attempted. Programmatically throttled to ≤200 queries/minute, and each run also enforces maxApiRequests.
• Upstream timeout is 15 seconds per attempt, bounded to three attempts with exponential backoff for 429, 5xx and networking timeouts; respects bounded Retry-After seconds. All secrets stay in process memory (never logged or written to a dataset).
• A SHA-256 filter fingerprint, K-number set, page position and default-dataset reconstruction support restart of the same Actor run without duplicate leads. A different filter cannot reuse a populated run's checkpoint.
• Classification lookups are cached by product code and count toward the request cap.

Pricing and costs

Target Store price: USD $0.007 per unique default Dataset item (1,000 = $7). Configure the Apify pay-per-event pricing in the Actor Publishing → Monetization section, using the synthetic apify-default-dataset-item event at $0.007; remove or set the apify-actor-start charge to $0 so no additional per-run amount is charged. Do not configure an extra custom result event: automatic default-dataset charging would then double charge.

Input maxCostUsd caps records based on $0.007 per item. The Apify UI max-total-charge cap may impose a stricter upper bound. Whether infrastructure usage is absorbed by the creator or separately charged must be checked on the listing price page; if separately passed on, API-event input limit does not bound that separate usage. At the publisher's advertised price, 80% of event revenue is shareable before Apify platform usage costs (i.e. $0.0056 per record before infrastructure expense), subject to Apify terms. For fast/cheap runs no proxy is needed.

Local development and QA

cd /opt/NEWAPI/NEWAPI25
npm ci
npm test
npx apify-cli validate-schema
# Apify local CLI, or run an Actor on the platform:
# npx apify-cli run --purge

Live test examples (October 2026, confirm they still exist):

{"decisionDateFrom":"2026-09-01","decisionDateTo":"2026-10-23","medicalSpecialty":"CV","maxResults":2,"maxCostUsd":0.014}

{"decisionDateFrom":"2026-09-01","decisionDateTo":"2026-10-23","medicalSpecialty":"RA","maxResults":2,"maxCostUsd":0.014}

Compliance and limitations

No enrichment from non-FDA, broker, personal/social, or historical hidden records is performed. User must verify the company and market status independently before outreach. Not for patient care, regulatory substantiation, or safety assessments. This is a monthly-updated regulatory signal, not a real-time market entry alert.

Official FDA documentation: 510(k) API, searchable fields, API limits, 510(k) decision process.

Apify: PPE monetization, pricing and costs.