Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alphamedix, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
137 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852706 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 | 131 | 0 |
| K852633 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 | 137 | 0 |
| K851272 | VERSAPHAGE | Alphamedix, Inc. | 1985-07-05 | 95 | 0 |
| K830812 | ALPHAMEDIX I/A HAND-PIECE, 500-001 | Alphamedix, Inc. | 1983-06-08 | 85 | 0 |
| K830703 | GLOMARK | Alphamedix, Inc. | 1983-04-28 | 52 | 0 |
| K820363 | DISPOSABLE SURGICAL GARMENTS | Alphamedix, Inc. | 1982-03-08 | 27 | 0 |
| K820008 | VERSATOME I | Alphamedix, Inc. | 1982-02-22 | 49 | 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