Cardiac Science Corporation: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Cardiac Science Corporation” (first 1997, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 126 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 | 1 | 520 |
| 2015 | 1 | 126 |
| 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 17 | 17 |
| DPS | Electrocardiograph | 3 | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Cardiovascular (21)
Most recent Cardiac Science Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143714 | Powerheart G5 AED | MKJ | 2015-05-04 | 126 |
| K122758 | POWERHEART G5 AED | MKJ | 2014-02-12 | 520 |
| K113176 | MYSENSE HEART | DSH | 2011-12-21 | 54 |
| K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS | MKJ | 2011-06-09 | 282 |
| K093211 | CARECENTER MD | DPS | 2010-06-03 | 233 |
| K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A | MKJ | 2009-09-10 | 72 |
| K082090 | 9131 DEFIBRILLATION ELECTRODES | MKJ | 2008-12-12 | 141 |
| K082173 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S | DPS | 2008-08-26 | 25 |
| K060934 | MODIFICATION TO POWERHEART ECD | MKJ | 2006-05-15 | 40 |
| K060167 | ATRIA 3100, ATRIA 6100 | DPS | 2006-04-19 | 86 |
11 earlier clearances. See the full list in Caduvo.
Recalls
48 product recalls in 19 recall events; 0 initiated in the last five years. Most recent: 2019-06-04.
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 Resucitator Corp. (17 510(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 Science Corporation?
FDA lists 21 510(k) clearances under the applicant name “Cardiac Science Corporation” (first 1997, latest 2015), 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 Science Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiac Science Corporation is 126 days.
Which FDA product codes appear under Cardiac Science Corporation?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 17); DPS (Electrocardiograph, 3); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 21 Cardiac Science Corporation clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Cardiac Science Corporation'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.