Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Proact, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
131 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941256 | QUICK CORE II | Proact, Ltd. | 1994-07-13 | 121 | 0 |
| K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS | Proact, Ltd. | 1993-03-22 | 81 | 0 |
| K913306 | BONE-TEMNO/STERNUM-TEMNO | Proact, Ltd. | 1991-11-01 | 99 | 1 |
| K902320 | BAUER FLEXI-TEMNO BIOPSY NEEDLE | Proact, Ltd. | 1990-10-01 | 131 | 0 |
| K902319 | BAUER TEMNO BIOPSY NEEDLE | Proact, Ltd. | 1990-09-06 | 106 | 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