Oxoid Limited (Part of Thermo Fisher Scientific): FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Oxoid Limited (Part of Thermo Fisher Scientific)” (first 2018, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 224 days. Since 2017 the median was 224 days, against 62 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 65 |
| 2019 | 0 | — |
| 2020 | 1 | 352 |
| 2021 | 2 | 220 |
| 2022 | 1 | 672 |
| 2023 | 1 | 67 |
| 2024 | 1 | 276 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oxoid Limited (Part of Thermo Fisher Scientific) took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 62 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 7 | 7 |
Review panels
- Microbiology (7)
Most recent Oxoid Limited (Part of Thermo Fisher Scientific) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | JTN | 2024-03-22 | 276 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | JTN | 2023-10-06 | 67 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | JTN | 2022-09-15 | 672 |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | JTN | 2021-10-27 | 217 |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | JTN | 2021-07-30 | 224 |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | JTN | 2020-12-04 | 352 |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | JTN | 2018-09-27 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Oxoid Limited (Part of Thermo Fisher Scientific).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Oxoid U.S.A., Inc. (93 510(k)s)
- Oxoid , Ltd. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oxoid Limited (Part of Thermo Fisher Scientific)?
FDA lists 7 510(k) clearances under the applicant name “Oxoid Limited (Part of Thermo Fisher Scientific)” (first 2018, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oxoid Limited (Part of Thermo Fisher Scientific)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxoid Limited (Part of Thermo Fisher Scientific) is 224 days. Since 2017: 224 days, versus 62 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oxoid Limited (Part of Thermo Fisher Scientific)?
The most frequent FDA product codes under this applicant name are JTN (Susceptibility Test Discs, Antimicrobial, 7).
Next steps
- See all 7 Oxoid Limited (Part of Thermo Fisher Scientific) clearances with predicates and recalls
- Run predicate analysis for product code JTN, Oxoid Limited (Part of Thermo Fisher Scientific)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.