Feed · openFDA 510(k) / PMA · $0.05 per 1,000-row page
FDA Device Clearances
The device-launch signal, straight from openFDA. Each row is a 510(k) clearance or PMA premarket approval — a device cleared to market — with the applicant (manufacturer), the device and generic name, product code, advisory-committee specialty panel, pathway, and the decision. Rows come newest-first by decision date. Observational public records as filed: never a recommendation.
The base: 232,324 device clearances and approvals — 175,559 510(k) clearances and 56,765 PMA premarket approvals. Every row carries event_date plus as_published_date (point-in-time discipline, no restatements).
Provenance
Every clearance, one flat row
- openFDA — device 510(k) & PMArefreshed weekly (per openFDA refresh)
FDA device 510(k) clearances and PMA premarket approvals — the applicant (manufacturer), device and generic name, product code, advisory-committee specialty panel, pathway, decision and description, and decision/received dates. A new clearance or approval is a device-launch moment for the applicant.
https://open.fda.gov
510(k) and PMA. pathway separates the two tracks; advisory_committee is the FDA specialty panel, so you can scope to a therapeutic area.
Attestation. Every API response carries a signed _meta attestation and the openFDA source vintage, so any clearance traces back to the public record.
Observational. A clearance appears with an applicant, a device, and a decision date as filed — never a recommendation.
Who buys this
Documented use cases
01Medical-device sales / BD
- Asks
- “Which manufacturers just cleared a device in my specialty — competing or complementary launches?”
- The feed returns
- One row per clearance — applicant, device, product code, and specialty panel — filterable by applicant, state, product code, pathway, or committee.
- Action
- Track launches by specialty the day the FDA decision posts, and time supplier and channel outreach to a fresh clearance.
02Device supplier / contract manufacturer
- Asks
- “Which applicants just cleared a device and will need components, packaging, or sterilization?”
- The feed returns
- Newest-first clearances with the applicant, device type, and pathway — a dated launch signal.
- Action
- Reach a manufacturer at the launch moment, by product code and specialty.
03Equity / research
- Asks
- “Which of my names carry a fresh 510(k) or PMA as a device-launch catalyst?”
- The feed returns
- Clearance rows by applicant with a stable event_key and pathway — drained by cursor, never restated.
- Action
- Track device-launch catalysts on medtech names the day the decision posts.
Schema
Fields & sample rows
| Field | Type | Description |
|---|---|---|
| event_key | text | Stable dedupe / cursor key: device:<decision_id>. |
| event_date | date | The decision date (= decision_date). The feed's `since` axis and sort key. |
| applicant | text | Applicant (manufacturer) company name. |
| decision_id | text | FDA decision id (K-number for 510(k), P-number for PMA). |
| pathway | text | 510k | pma — the regulatory pathway. |
| device_name / generic_name | text | Trade device name and the generic device type. |
| product_code | text | FDA 3-letter product code. |
| advisory_committee | text | The FDA medical-specialty panel (Cardiovascular, Radiology, ...). |
| clearance_type | text | Traditional / Abbreviated / Special (510(k)) or the PMA review track. |
| decision_code / decision_description | text | The decision code and its description (e.g. Substantially Equivalent). |
| state | text | Applicant state where present. |
| date_received | date | Date the submission was received by the FDA. |
| as_published_date | date | Source-file vintage the row was last published in — rows are never restated. |
Full machine-readable endpoint definition (parameters, output shape, price) lives in the catalog at api.govparse.io/v1/catalog and in every Snowflake / Datarade listing.
| decision_date | applicant | device_name | specialty | product_code | pathway | state |
|---|---|---|---|---|---|---|
| 2026-07-10 | ABBOTT MEDICAL | Volt PFA System | Cardiovascular | QZI | pma | MN |
| 2026-07-10 | Medtronic, Inc. | HexaGen RF Generator Software and Remote | Cardiovascular | QZI | pma | MN |
| 2026-07-10 | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Microbiology | LSR | 510k | CA |
Real rows from GET /v1/feeds/fda-device-clearances (openFDA 510(k) / PMA as filed; columns abridged). Each row also carries generic_name, clearance_type, decision_description, and date_received.
Pricing & access
Three ways to buy
Self-serve API
$0.05 / page
up to 1,000 rows per page-call — live today
- Full feed, every filter, opaque keyset cursor
- Pay per use: x402 (USDC, no account) or a metered API key
- Signed _meta attestation and source vintages on every response
- No seat licenses, no minimums, no sales call
Enterprise
$10,000 / yr
flat annual license
- Bulk daily or weekly drops (CSV / Parquet) to your bucket
- Webhook alerts on new rows matching your saved filters
- Private Snowflake share of the same tables
- Email support and a named contact
Institutional
Private offer
the tier comparable products price at $40–85k/yr
- Everything in Enterprise
- Ticker/CIK-mapped rows — identifier-verified against the SEC registrant universe, match basis disclosed
- Point-in-time discipline: event_date + as_published_date on every row, no restatements, vintage history retained
- Delivery SLA, methodology documentation, and diligence support for your data-sourcing review
- $0.05 per page-call — each call returns up to 1,000 flat rows. Drain any window with repeated cursor calls; the opaque keyset cursor never skips or double-counts a row.
- Pay-per-use, two ways: x402 (USDC, no account needed — pay per request) or a metered API key with monthly billing.
- Warehouse-native delivery: the same feeds are listed on Datarade and coming to Snowflake Marketplace (listings submitted, in review) — enterprise buyers get a private Snowflake share today — plus CSV export for flat-file workflows.
- Full machine-readable endpoint definitions (parameters, output shape, prices) live in the catalog at api.govparse.io/v1/catalog; dataset license terms at api.govparse.io/v1/license/fda.
curl "https://api.govparse.io/v1/feeds/fda-device-clearances?committee=Cardiovascular&pathway=pma&limit=500" \
-H "x-api-key: gp_live_..."GET https://api.govparse.io/v1/feeds/fda-device-clearances
Start pulling pages today.
No sales call. First page is one x402 payment away, or grab a metered key.