Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ceramatec, 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) |
|---|---|---|---|---|---|
| K972992 | CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS | Ceramatec, Inc. | 1998-03-30 | 230 | 0 |
| K973282 | HANDI OXYGEN ANALYZER | Ceramatec, Inc. | 1998-03-04 | 183 | 0 |
| K911344 | CERION HAND HELD OXYGEN ANALYZER | Ceramatec, Inc. | 1991-06-18 | 83 | 0 |
| K880448 | CERION OXY THRESHOLD ALARM | Ceramatec, Inc. | 1988-03-21 | 48 | 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