Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

ZOLL Medical Corporation · Predicate Candidate Screening

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

165 daysmedian FDA review time

316 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233486	731 Series Ventilator	ZOLL Medical Corporation	2024-12-13	413	0
K202375	ZOLL Propaq M	ZOLL Medical Corporation	2021-03-09	201	0
K180482	ZOLL Propaq M	ZOLL Medical Corporation	2018-11-30	280	0
K172653	Power Infuser	ZOLL Medical Corporation	2018-07-18	316	0
K162832	731 Series Ventilators	ZOLL Medical Corporation	2017-08-02	295	1
K170533	Model 330 Multifunction Aspirator	ZOLL Medical Corporation	2017-04-18	54	0
K142915	ZOLL X Series	ZOLL Medical Corporation	2014-12-03	57	0
K141774	ZOLL X SERIES	ZOLL Medical Corporation	2014-11-19	140	0
K140502	ZOLL E SERIES ALS	ZOLL Medical Corporation	2014-11-06	252	0
K132488	ZOLL CODE WRITER	ZOLL Medical Corporation	2014-04-03	238	0
K131919	ZOLL EPCR IOS	ZOLL Medical Corporation	2013-12-17	174	0
K122839	ZOLL SUREPOWER SINGLE BAY CHARGER	ZOLL Medical Corporation	2012-12-13	87	0
K121865	ZOLL RESCUENET 12-LEAD	ZOLL Medical Corporation	2012-11-20	147	0
K121367	ZOLL PROPAQ XM	ZOLL Medical Corporation	2012-06-21	45	1
K103473	ZOLL RESCUENET EPCR MODEL RESCUENET EPCR	ZOLL Medical Corporation	2011-05-13	170	0
K110978	ONESTEP PEDIATRIC MFE'S	ZOLL Medical Corporation	2011-05-13	36	0
K110742	ONESTEP ADULT MULTI-FUNCTION ELECTRODE	ZOLL Medical Corporation	2011-04-13	27	0
K110526	ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE	ZOLL Medical Corporation	2011-03-25	29	0
K091561	ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE	ZOLL Medical Corporation	2010-09-23	483	0
K090736	POWER INFUSER, MODEL M100B-3A	ZOLL Medical Corporation	2009-05-20	62	0
K081828	ZOLL R SERIES BLS DEFIBRILLATOR	ZOLL Medical Corporation	2008-12-09	165	0
K080903	ZOLL E SERIES WITH INTIBATION ASSIST OPTION	ZOLL Medical Corporation	2008-12-04	247	0
K081574	ZOLL R SERIES	ZOLL Medical Corporation	2008-09-18	105	0
K072430	ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE	ZOLL Medical Corporation	2007-11-06	69	1
K062537	ZOLL M SERIES WITH REAL CPR HELP	ZOLL Medical Corporation	2007-02-28	183	0
K062177	ZOLL E SERIES WITH REAL CPR HELP	ZOLL Medical Corporation	2006-12-13	135	0
K060559	ZOLL R SERIES DEFIBRILLATOR	ZOLL Medical Corporation	2006-08-17	168	1
K051475	ZOLL M SERIES 12SL ANALYSIS OPTION	ZOLL Medical Corporation	2005-06-24	21	0
K051076	ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES	ZOLL Medical Corporation	2005-05-13	16	1
K041892	ZOLL AED PRO EXTERNAL DEFIBRILLATOR	ZOLL Medical Corporation	2005-02-04	206	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