Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Simpex, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
129 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920174 | EASY TOUCH LATEX EAM GLOVES | Simpex, Inc. | 1992-04-22 | 99 | 0 |
| K913793 | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | Simpex, Inc. | 1991-12-30 | 129 | 0 |
| K913794 | SIMPEX INC. SURGICAL DRESSING | Simpex, Inc. | 1991-11-20 | 89 | 0 |
| K911452 | FIXATION PIN | Simpex, Inc. | 1991-04-12 | 9 | 0 |
| K911505 | FIXATION WIRE | Simpex, Inc. | 1991-04-12 | 8 | 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