Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ORQ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
19 daysmedian FDA review time
54 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250395 | BioBrace ® RC Delivery System | Conmed Corporation | 2025-04-07 | 54 | 0 |
| K130782 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2013-04-05 | 15 | 0 |
| K123066 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-10-16 | 15 | 0 |
| K121139 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-05-02 | 16 | 0 |
| K103269 | PATCHASSIST LARGE | Polytouch Medical, Ltd. | 2010-11-23 | 19 | 0 |
| K101218 | PATCHASSIST | Polytouch Medical, Ltd. | 2010-06-17 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda