Oxford Instruments Medical Systems: FDA clearances and approvals
Oxford Instruments Medical Systems has 5 FDA 510(k) clearances (first 1995, latest 2001), across 4 product codes in 3 review panels. Median 510(k) review time: 263 days.
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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Cardiovascular (2)
- Neurology (2)
- Obstetrics and Gynecology (1)
Most recent Oxford Instruments Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992607 | SONICAID SYSTEM 8002 | HGM | 2001-04-27 | 633 |
| K984052 | SYNERGY IOM SYSTEM | IKN | 1999-05-17 | 185 |
| K970902 | MEDILOG FD4 | DSH | 1997-05-05 | 55 |
| K961638 | MEDILOG MPA-S | OLV | 1997-01-17 | 263 |
| K943862 | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER | DSH | 1995-06-07 | 303 |
Recalls
openFDA lists no recalls under a recalling firm named Oxford Instruments Medical Systems.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Oxford Instruments Medical Systems have?
Oxford Instruments Medical Systems has 5 FDA 510(k) clearances (first 1995, latest 2001), across 4 product codes in 3 review panels.
How long does FDA take to clear Oxford Instruments Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Oxford Instruments Medical Systems's cleared 510(k)s is 263 days.
What devices does Oxford Instruments Medical Systems make?
Its most frequent FDA product codes are DSH (Recorder, Magnetic Tape, Medical, 2); HGM (System, Monitoring, Perinatal, 1); IKN (Electromyograph, Diagnostic, 1).
Has Oxford Instruments Medical Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Oxford Instruments Medical Systems. Related entities may recall under other names.
Next steps
- See all 5 Oxford Instruments Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code DSH, Oxford Instruments Medical Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.