Del Mar Reynolds Medical, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Del Mar Reynolds Medical, Ltd.” (first 2004, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (1)
Most recent Del Mar Reynolds Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062397 | SENTINEL | DXH | 2007-01-25 | 162 |
| K062469 | VOYAGER 12 | DPS | 2006-11-03 | 71 |
| K051960 | CARDIONAVIGATOR + | DXH | 2005-08-19 | 31 |
| K042745 | LIFESCREEN APNEA | MNR | 2005-01-19 | 107 |
| K040313 | HRV TOOLS | DPS | 2004-04-06 | 57 |
Recalls
12 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2017-04-14.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Del Mar Reynolds Medical, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Del Mar Reynolds Medical, Ltd.” (first 2004, latest 2007), across 3 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 Del Mar Reynolds Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Del Mar Reynolds Medical, Ltd. is 71 days.
Which FDA product codes appear under Del Mar Reynolds Medical, Ltd.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 2); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 5 Del Mar Reynolds Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Del Mar 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.