Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adven Medical · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
182 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021528 | REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP | Adven Medical | 2002-08-21 | 103 | 0 |
| K013987 | REPROCESSED DISPOSABLE TROCARS | Adven Medical | 2002-03-01 | 87 | 0 |
| K012675 | REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/W | Adven Medical | 2002-02-12 | 182 | 0 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | 2002-02-04 | 174 | 0 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 | 174 | 0 |
| K940501 | RE-SHARPENABLE SAW BLADES | Adven Medical | 1994-06-28 | 146 | 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