Oxford Performance Materials, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Oxford Performance Materials, Inc.” (first 2013, latest 2019), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 212 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 232 |
| 2014 | 1 | 224 |
| 2015 | 1 | 352 |
| 2016 | 1 | 97 |
| 2017 | 0 | — |
| 2018 | 1 | 199 |
| 2019 | 1 | 85 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oxford Performance Materials, Inc. took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 2 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
Review panels
- Neurology (2)
- Orthopedic (2)
- General and Plastic Surgery (2)
Most recent Oxford Performance Materials, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190915 | OsteoFab Suture Anchors | MBI | 2019-07-03 | 85 |
| K180064 | OsteoFab Patient Specific Cranial Device | GXN | 2018-07-27 | 199 |
| K161052 | OsteoFab Patient Specific Facial Device | KKY | 2016-07-20 | 97 |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | MQP | 2015-07-10 | 352 |
| K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | KKY | 2014-07-28 | 224 |
| K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | GXN | 2013-02-07 | 232 |
Recalls
openFDA lists no recalls under a recalling firm named Oxford Performance Materials, Inc..
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.
- Oxford Medilog, Inc. (48 510(k)s)
- Oxford Laboratories, Inc. (9 510(k)s)
- Oxford Instruments Medical Systems (5 510(k)s)
- Oxford Instruments, Plc. (5 510(k)s)
- Oxford Biosignals Limited (4 510(k)s)
- Oxford Instruments (2 510(k)s)
- Oxford Medical, Inc. (2 510(k)s)
- Oxford Metrics, Inc. (2 510(k)s)
- Oxford Brain Diagnostics, Ltd. (1 510(k)s)
- Oxford Instruments Medical , Ltd. (1 510(k)s)
- Oxford Immunotec, Ltd. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oxford Performance Materials, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Oxford Performance Materials, Inc.” (first 2013, latest 2019), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oxford Performance Materials, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxford Performance Materials, Inc. is 212 days.
Which FDA product codes appear under Oxford Performance Materials, Inc.?
The most frequent FDA product codes under this applicant name are GXN (Plate, Cranioplasty, Preformed, Non-Alterable, 2); KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, 2); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 1).
Next steps
- See all 6 Oxford Performance Materials, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXN, Oxford Performance Materials, Inc.'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.