Cardiac Resucitator Corp.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Cardiac Resucitator Corp.” (first 1981, latest 1988), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 13 | 13 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| LDO | Enzymatic Radiochemical Assay, Tobramycin | 1 | 1 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (15)
- Clinical Toxicology (1)
Most recent Cardiac Resucitator Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882513 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | DSI | 1988-07-12 | 40 |
| K871971 | MODIFIED PACE*AID MODEL 53 | DRO | 1987-06-24 | 34 |
| K871538 | STAT-PAD (TM) | DRO | 1987-06-24 | 65 |
| K871569 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | DRO | 1987-06-08 | 45 |
| K870622 | HEART*AID 1000 | MKJ | 1987-04-10 | 57 |
| K850596 | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & | DRO | 1985-03-06 | 19 |
| K850170 | HEART AID MODEL 97 | DRO | 1985-02-14 | 29 |
| K844811 | PACE AID MODEL 53 | DRO | 1985-01-24 | 44 |
| K843547 | PACE *AID MODEL 52 | DRO | 1984-12-17 | 98 |
| K843358 | HEART-AID MODEL 80 | DRO | 1984-11-19 | 84 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiac Resucitator Corp..
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 Recorders, Ltd. (8 510(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 Resucitator Corp.?
FDA lists 17 510(k) clearances under the applicant name “Cardiac Resucitator Corp.” (first 1981, latest 1988), across 5 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 Cardiac Resucitator Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiac Resucitator Corp. is 57 days.
Which FDA product codes appear under Cardiac Resucitator Corp.?
The most frequent FDA product codes under this applicant name are DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 13); DSI (Detector And Alarm, Arrhythmia, 1); LDO (Enzymatic Radiochemical Assay, Tobramycin, 1).
Next steps
- See all 17 Cardiac Resucitator Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRO, Cardiac Resucitator Corp.'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.