Cardiac Recorders, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cardiac Recorders, Ltd.” (first 1985, latest 1987), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Cardiac Recorders, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864704 | CARDIAN III CR6A | DPS | 1987-03-20 | 108 |
| K861621 | CARDIAN II CR45A | DRT | 1986-09-12 | 136 |
| K853673 | CARDIORATER CR 51 | DRT | 1985-12-11 | 98 |
| K852910 | CARDIORATER CR7 | DRT | 1985-11-19 | 133 |
| K852887 | CR5 CARDIAC MONITOR | DRT | 1985-11-14 | 128 |
| K852905 | CR 280/45, CR281/4 DEFIBRILLATOR | LDD | 1985-11-05 | 119 |
| K852808 | CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) | LDD | 1985-09-16 | 76 |
| K852799 | 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR) | LDD | 1985-09-16 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiac Recorders, 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.
- Cardiac Pacemakers, Inc. (76 510(k)s)
- Cardiac Control Systems, Inc. (26 510(k)s)
- Cardiac Science Corporation (21 510(k)s)
- Cardiac Resucitator Corp. (17 510(k)s)
- Cardiac Pathways Corp. (5 510(k)s)
- Cardiac Assist Devices, Inc. (3 510(k)s)
- Cardiac Designs, LLC (3 510(k)s)
- Cardiac Insight, Inc. (3 510(k)s)
- Cardiac Assist, Maquet Cardiovascular, LLC (2 510(k)s)
- Cardiac Evaluation Center, Inc. (2 510(k)s)
- Cardiac Mariners, Inc. (2 510(k)s)
- Cardiac Telecom Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiac Recorders, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Cardiac Recorders, Ltd.” (first 1985, latest 1987), across 3 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 Cardiac Recorders, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiac Recorders, Ltd. is 114 days.
Which FDA product codes appear under Cardiac Recorders, Ltd.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 3); DPS (Electrocardiograph, 1).
Next steps
- See all 8 Cardiac Recorders, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Cardiac Recorders, 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.