Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Chemetron Medical Products, 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) |
|---|---|---|---|---|---|
| K781706 | RESPIRATOR/GILL 1/SIMV | Chemetron Medical Products, Inc. | 1979-01-22 | 104 | 0 |
| K781537 | NEBULIZER/HUMIDIFIER | Chemetron Medical Products, Inc. | 1978-10-10 | 39 | 0 |
| K781542 | HEATED NEBULIZER | Chemetron Medical Products, Inc. | 1978-10-10 | 32 | 0 |
| K781541 | FLOMETER | Chemetron Medical Products, Inc. | 1978-09-26 | 18 | 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