Oxford Instruments, Plc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oxford Instruments, Plc.” (first 1994, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 263 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | 2 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
Most recent Oxford Instruments, Plc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981405 | SYNERGY LT | GWF | 1998-07-16 | 87 |
| K961642 | MEDILOG MR95 | GWQ | 1997-01-17 | 263 |
| K961636 | MEDILOG VISION | OLZ | 1997-01-17 | 263 |
| K930714 | SONICAID MODEL TEAM FECG IUP | HEL | 1995-08-24 | 924 |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | HEL | 1994-12-22 | 505 |
Recalls
openFDA lists no recalls under a recalling firm named Oxford Instruments, Plc..
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 Performance Materials, Inc. (6 510(k)s)
- Oxford Instruments Medical Systems (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 Instruments, Plc.?
FDA lists 5 510(k) clearances under the applicant name “Oxford Instruments, Plc.” (first 1994, latest 1998), across 4 product codes in 2 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 Instruments, Plc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxford Instruments, Plc. is 263 days.
Which FDA product codes appear under Oxford Instruments, Plc.?
The most frequent FDA product codes under this applicant name are HEL (Monitor, Heart Rate, Fetal, Ultrasonic, 2); GWF (Stimulator, Electrical, Evoked Response, 1); GWQ (Full-Montage Standard Electroencephalograph, 1).
Next steps
- See all 5 Oxford Instruments, Plc. clearances with predicates and recalls
- Run predicate analysis for product code HEL, Oxford Instruments, Plc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.