Know every FDA device clearance. And what happened after.
510(k) clearances and recalls, cross-linked and queryable. Find predicates in minutes, see real FDA review times, and get alerted when your market moves.
175,812clearances indexed
45,411recalls indexed
55,503pmas indexed
34,427manufacturers
21medical specialties
Built for the people who live in this data
Regulatory consultants
Every clearance page lists devices sharing its product code - your predicate candidate set - plus median and 90th-percentile FDA review times for that code.
Explore product codes →Medtech teams
See a competitor's entire clearance history, their recalls, and how fast their submissions cleared - on one manufacturer page.
Look up a manufacturer →CROs & suppliers
A fresh clearance is a buying signal. The change feed surfaces every new clearance and recall the week it posts - as an API or a weekly email.
See the change feed →Query it like a database, because it is one
curl "https://atlasbyauro.com/v1/clearance?manufacturer=Medtronic,%20Inc.&limit=5&key=YOUR_KEY"
const r = await fetch(
"https://atlasbyauro.com/v1/changes?since=2026-08-01&key=" + KEY
);
const { results } = await r.json(); // this week's new clearances
import requests
r = requests.get("https://atlasbyauro.com/v1/clearance",
params={"product_code": "LZG", "limit": 100, "key": KEY})
devices = r.json()["results"]
Latest FDA 510(k) clearances
| Record | Organization | Date |
|---|---|---|
| Zamenix™ P (K253505) | Roen Surgical, Inc. | 2026-08-07 |
| Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702) | Intuitive Surgical, Inc. | 2026-08-07 |
| Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) (K251544) | Lakong Medical Devices Co., Ltd. | 2026-08-07 |
| BUM Oil (K261905) | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 |
| mdprostate (K252571) | Mediaire GmbH | 2026-08-07 |
| Mistral-Air® Warming System (K261437) | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 |
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Metrix COVID Test; Metrix COVID Test Pro (K253453) | Aptitude Medical Systems, Inc. | 2026-08-07 |
| Xpert Hemorrhagic Fever (K261362) | Cepheid | 2026-08-07 |
| Aperio GT 450 DX; Aperio GT 180 DX (K253554) | Leica Biosystems Imaging, Inc. | 2026-08-07 |
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New to this data?
What is a 510(k) clearance?
Before most medical devices can be sold in the US, the manufacturer must show FDA the device is safe and effective. The 510(k) pathway does this by demonstrating the device is "substantially equivalent" to one already on the market. When FDA agrees, the device is "cleared" and gets a K-number. About 3,000 devices clear this way every year.
What is a predicate device, and why does everyone search for them?
The already-cleared device you compare yours against is the "predicate." Choosing a strong predicate is the single most important decision in a 510(k) submission, and finding candidates means digging through devices with the same product code - which is exactly what every clearance page here lists automatically.
How long does FDA take to clear a device?
It varies enormously by product code - some clear in 30 days, others take over a year. Every product-code page here shows the median and 90th-percentile review time computed from the actual record.
Where does this data come from?
The FDA's own openFDA releases, refreshed weekly. We organize, link, and index it - the underlying records are public data. For anything of regulatory consequence, always confirm against the primary source.
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