Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Simplex Medical Systems, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970249 | SIMPLEX AIRBRATOR | Simplex Medical Systems, Inc. | 1997-05-07 | 105 | 0 |
| K932288 | NEONATAL BREATHING CIRCUIT MODIFICATION | Simplex Medical Systems, Inc. | 1994-12-30 | 599 | 0 |
| K904396 | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM | Simplex Medical Systems, Inc. | 1991-03-05 | 161 | 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