Oxford Medilog, Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Oxford Medilog, Inc.” (first 1978, latest 1994), across 20 product codes in 7 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 14 | 14 |
| DSH | Recorder, Magnetic Tape, Medical | 6 | 6 |
| GWQ | Full-Montage Standard Electroencephalograph | 6 | 6 |
| HGM | System, Monitoring, Perinatal | 3 | 3 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Plus 10 more product codes.
Review panels
- Cardiovascular (25)
- Neurology (13)
- Obstetrics and Gynecology (3)
- Anesthesiology (2)
- Gastroenterology and Urology (2)
- Physical Medicine (2)
- Radiology (1)
Most recent Oxford Medilog, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923737 | MODEL MEDILOG RAPIDE | BZQ | 1994-01-05 | 527 |
| K920295 | MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) | DQK | 1992-08-18 | 209 |
| K912890 | MODEL SONICAID AXIS | HGM | 1992-01-09 | 192 |
| K912639 | SONICAID TEAM | HGM | 1991-12-31 | 200 |
| K904763 | MENTOR EEG SYSTEM | GWQ | 1991-04-10 | 170 |
| K902690 | SONICAID MODEL MERIDIAN 800 | HGM | 1991-02-05 | 231 |
| K895909 | SONICAID MODEL VASOFLO 4 | MAA | 1990-07-09 | 272 |
| K896535 | MEDILOG OPTIMA | DSK | 1990-01-18 | 65 |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | OLZ | 1989-06-01 | 84 |
| K890330 | MEDILOG 6000-FD REPORT GENERATOR | DSI | 1989-04-20 | 87 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oxford Medilog, 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 Laboratories, Inc. (9 510(k)s)
- Oxford Performance Materials, Inc. (6 510(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 Medilog, Inc.?
FDA lists 48 510(k) clearances under the applicant name “Oxford Medilog, Inc.” (first 1978, latest 1994), across 20 product codes in 7 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 Medilog, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxford Medilog, Inc. is 80 days.
Which FDA product codes appear under Oxford Medilog, Inc.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 14); DSH (Recorder, Magnetic Tape, Medical, 6); GWQ (Full-Montage Standard Electroencephalograph, 6).
Next steps
- See all 48 Oxford Medilog, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Oxford Medilog, 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.