Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zefon Medical Products · 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) |
|---|---|---|---|---|---|
| K940220 | REBREATHER BAGS | Zefon Medical Products | 1994-05-27 | 126 | 0 |
| K934462 | ADULT ANESTHESIA BREATHING CIRCUIT KITS | Zefon Medical Products | 1994-03-01 | 169 | 0 |
| K930957 | ZEFON GAS SAMPLING LINES | Zefon Medical Products | 1993-07-02 | 129 | 0 |
| K924889 | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT | Zefon Medical Products | 1993-03-19 | 172 | 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