Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAH · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
297 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110355 | VENX REVOLUTION | Venx, LLC | 2011-04-22 | 74 | 0 |
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | Advanced Medical Products, Inc. | 2000-05-17 | 55 | 0 |
| K970306 | MARKMAN TEMPLATE SYSTEM | Barry Markman, M.D. | 1997-11-20 | 297 | 0 |
| K972918 | RAPID FIRE HAIR IMPLANTER CAROUSEL | Apex Medical Products, LLC | 1997-10-27 | 81 | 0 |
| K972521 | NAVIGATOR (STYLET) 2006 | Sil-Med Corp. | 1997-10-01 | 86 | 0 |
| K952737 | CALVITRON HAIR TRANSPLANT SYSTEM | Medicamat S.A. | 1995-10-03 | 110 | 0 |
| K770970 | HAIR TRANSPLANT PUNCH, MULTIPLH | Padgett Instruments, Inc. | 1977-10-27 | 149 | 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