Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Franklin Medical USA, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931488 | KSF SPINAL FIXATOR | Franklin Medical USA, Inc. | 1994-01-21 | 302 | 0 |
| K884589 | FRANTZ MEDICAL SHARPS COLLECTOR | Franklin Medical USA, Inc. | 1988-12-09 | 36 | 0 |
| K862478 | HAYES VAGINAL SHIELD | Franklin Medical USA, Inc. | 1986-11-24 | 147 | 0 |
| K852200 | SIMPLASTIC SUPRA PUBIC CATHETER | Franklin Medical USA, Inc. | 1985-08-07 | 78 | 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