Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fenem, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
63 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894429 | MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1989-09-18 | 63 | 0 |
| K894053 | 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1989-07-20 | 43 | 0 |
| K884080 | MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1988-10-21 | 24 | 0 |
| K883950 | MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER | Fenem, Inc. | 1988-09-29 | 21 | 0 |
| K883821 | FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1988-09-26 | 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