Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Thermo Fisher Scientific (Oxoid Ltd.) · 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) |
|---|---|---|---|---|---|
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 | 56 | 0 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 | 219 | 0 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 | 90 | 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