Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Science, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
230 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052316 | POWERHEART ECD | Cardiac Science, Inc. | 2006-01-03 | 131 | 0 |
| K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC | Cardiac Science, Inc. | 2005-10-21 | 73 | 23 |
| K040637 | POWERHEART AED G3 PRO | Cardiac Science, Inc. | 2004-08-06 | 149 | 8 |
| K040438 | POWERHEART AED G3A | Cardiac Science, Inc. | 2004-07-01 | 133 | 25 |
| K022929 | PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, | Cardiac Science, Inc. | 2003-01-27 | 145 | 0 |
| K022210 | MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 | Cardiac Science, Inc. | 2002-10-04 | 88 | 0 |
| K012197 | POWERHEART CARDIAC RHYTHM MODULE | Cardiac Science, Inc. | 2001-11-16 | 126 | 1 |
| K993533 | POWERHEART AECD | Cardiac Science, Inc. | 2000-01-24 | 97 | 1 |
| K982710 | AECD ARRHYTHMIA DETECTION SOFTWARE | Cardiac Science, Inc. | 1998-08-10 | 6 | 1 |
| K970741 | POWERHEART AECD | Cardiac Science, Inc. | 1997-10-16 | 230 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda