510(k) Clearances
175,877
The regulatory intelligence layer
Every FDA decision,
Every FDA decision,
curated and connected.
Search clearances, approvals, recalls, adverse events and clinical trials in one connected, primary-source record — refreshed every week.
See pricing →Primary sourcesRefreshed weeklyFree to searchNo card for the free tier
PMA Approvals
56,972
Device Recalls
45,527
Clinical Trials
601,696
Data Verified
Sep 5, 2026
The Collection
Two references. One connected graph.
Every record links sideways: manufacturer to clearance, clearance to recall, sponsor to trial. The joins the source databases never made.
Live · Refreshed weekly
Atlas FDA
175,877 clearancesPredicate research that took an afternoon now takes a click. Screened against recalls, exportable as evidence.
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Live · Refreshed weekly
Atlas Trials
601,696 studiesEvery registered study, organized the way analysts actually ask. A sponsor's full pipeline in one view.
Explore trials →
Our Approach
We don't aggregate records.
We don't aggregate records.
We connect them.
A clearance means little until you can see the recalls that reference it, the adverse events reported against it, and fifty years of decisions around it. Atlas draws those lines, then keeps them current automatically from FDA and NLM primary sources.
How consultants use Atlas →NBW
509 FDA 510(k) clearances · Product code
153 daysmedian time to decision
429 days90th percentile
509clearances measured
Export predicate table (CSV)Shareable reportexports: 3 free/month · reports: free
| Record | Firm | Date |
|---|---|---|
| TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | 2026-07-23 |
| On Call® Sure GK Blood Glucose & Ketone System | ACON Laboratories, Inc. | 2025-10-10 |
153 daysmedian FDA review time
429 days90th percentile
509clearances measured
| K-number | Device | Applicant |
|---|---|---|
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. |
| K250085 | On Call® Sure GK Blood Glucose & Ketone System | ACON Laboratories, Inc. |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation |
| K240640 | Sejoy Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. |
From Question to Deliverable
Three steps. No sales call.
01
Search the record
By device, manufacturer, product code, sponsor or condition. Every page is a live view of the connected database.
02
Screen with evidence
Review times, recall history and adverse-event trends surface the risks the source databases keep in separate silos.
03
Export & automate
Client-ready screening tables and reports, or the JSON API with change alerts. Self-serve from free.
The Living Record
August, at the FDA.
The record isn't an archive. It moves. 120 devices cleared in August alone, and Atlas linked every one of them the week they posted. This calendar redraws itself after every refresh.
Read the weekly roundups →Decision ActivityAugust 2026
MTWTFSS12345678910111213141516171819202122232425262728293031
Decisions postedQuiet
120 clearances in August · busiest day August 14
Latest: CN-Suite™ (K260563)
Computed from the record · Redrawn weekly
What the Record Shows
Evidence, not testimonials.
Review Times
Blood glucose monitors clear in a median of 153 days. The slowest tenth take over 429. The full 2026 report →
On every product code
Cross-Linked
45,527 recalls joined to the clearances they reference, visible before a recalled device becomes your predicate.
On every device page & export
AI-Native
FDA has authorized 1,500+ AI-enabled devices and announces none of them. Atlas tracks the official list weekly, and AI assistants query all 880,072 records through our MCP server.
atlasbyauro.com/fda/ai-devices
Bespoke Research · Self-Serve Pricing
Begin with the record.
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