Reynolds Medical , Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Reynolds Medical , Ltd.” (first 1982, latest 2003), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 4 | 4 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (12)
Most recent Reynolds Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024283 | CARDIODIRECT, MODELS 12M, 12I, 12S | DPS | 2003-08-01 | 221 |
| K013367 | CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH | DPS | 2001-12-13 | 64 |
| K011345 | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM | DXH | 2001-07-20 | 79 |
| K011837 | LIFECARD CF 7 DAY | MWJ | 2001-07-13 | 31 |
| K001025 | LIFECARD CF COMPACT RECORDER | DSH | 2000-04-19 | 20 |
| K991211 | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM | DXH | 1999-07-08 | 90 |
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER | DXH | 1997-12-04 | 142 |
| K951902 | PATHFINDER 700 HOLTER ANALYZER | DQK | 1996-07-15 | 448 |
| K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER | DSH | 1994-10-20 | 105 |
| K884126 | E-RAM | DSH | 1989-10-30 | 395 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reynolds Medical , Ltd..
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.
- Reynolds Laboratories (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reynolds Medical , Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Reynolds Medical , Ltd.” (first 1982, latest 2003), across 6 product codes 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 Reynolds Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reynolds Medical , Ltd. is 98 days.
Which FDA product codes appear under Reynolds Medical , Ltd.?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 4); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 3); DPS (Electrocardiograph, 2).
Next steps
- See all 12 Reynolds Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DSH, Reynolds Medical , Ltd.'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.