Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oxoid Limited (Part of Thermo Fisher Scientific) · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
224 daysmedian FDA review time
672 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 | 276 | 0 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 | 67 | 0 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 | 672 | 0 |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 | 217 | 0 |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 | 224 | 0 |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2020-12-04 | 352 | 0 |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) ME | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 | 65 | 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