Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cardiac Science Corporation — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

126 daysmedian FDA review time

520 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143714	Powerheart G5 AED	Cardiac Science Corporation	2015-05-04	126	0
K122758	POWERHEART G5 AED	Cardiac Science Corporation	2014-02-12	520	0
K113176	MYSENSE HEART	Cardiac Science Corporation	2011-12-21	54	0
K102496	POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATI	Cardiac Science Corporation	2011-06-09	282	2
K093211	CARECENTER MD	Cardiac Science Corporation	2010-06-03	233	0
K091943	POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC,	Cardiac Science Corporation	2009-09-10	72	7
K082090	9131 DEFIBRILLATION ELECTRODES	Cardiac Science Corporation	2008-12-12	141	0
K082173	Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S	Cardiac Science Corporation	2008-08-26	25	1
K060934	MODIFICATION TO POWERHEART ECD	Cardiac Science Corporation	2006-05-15	40	2
K060167	ATRIA 3100, ATRIA 6100	Cardiac Science Corporation	2006-04-19	86	0

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