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

Zoll Medical Corp — Predicate Candidate Screening

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

179 daysmedian FDA review time

305 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133484	ZOLL X SERIES	Zoll Medical Corp	2014-08-01	261	0
K112660	POCKETCPR	Zoll Medical Corp	2012-05-10	240	0
K090989	ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES	Zoll Medical Corp	2009-09-23	169	0
K042007	ZOLL E SERIES DEFIBRILLATOR	Zoll Medical Corp	2005-04-07	255	3
K042302	ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERN	Zoll Medical Corp	2004-10-26	62	0
K042417	ZOLL M SERIES ETC02 LOFLO OPTION	Zoll Medical Corp	2004-10-05	28	0
K033474	ZOLL AED PLUS	Zoll Medical Corp	2004-05-21	200	1
K032691	ZOLL AUTOCLAVABLE INTERNAL HANDLES	Zoll Medical Corp	2003-11-13	72	0
K032439	ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI	Zoll Medical Corp	2003-11-05	90	0
K032363	ZOLL M SERIES NIBP OPTION	Zoll Medical Corp	2003-10-31	92	0
K011541	ZOLL PAD WITH CPR AID	Zoll Medical Corp	2002-04-11	328	0
K011388	ZOLL PAD	Zoll Medical Corp	2002-03-25	322	1
K011865	ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIO	Zoll Medical Corp	2001-07-31	47	0
K010257	ZOLL M SERIES	Zoll Medical Corp	2001-02-28	30	1
K002029	ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION	Zoll Medical Corp	2000-09-21	80	0
K993036	ZOLL M SERIES ETCO2 OPTION	Zoll Medical Corp	2000-02-28	172	0
K991556	ZOLL M SERIES 12SL ANALYSIS OPTION	Zoll Medical Corp	1999-10-21	170	0
K990762	ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI	Zoll Medical Corp	1999-09-03	179	0
K982992	ZOLL M SERIES SPO2 OPTION	Zoll Medical Corp	1999-03-11	196	0
K972241	ZOLL REVIVER	Zoll Medical Corp	1998-03-16	273	1
K963781	ZOLL AUTOCLAVABLE INTERNAL HANDLES	Zoll Medical Corp	1997-05-20	242	0
K960676	ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MOD	Zoll Medical Corp	1996-06-05	106	0
K950856	ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000,	Zoll Medical Corp	1995-12-29	305	0
K942344	ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR	Zoll Medical Corp	1995-03-13	301	0
K942850	ZOLL POWERBASE(TM)	Zoll Medical Corp	1995-02-10	239	0
K943698	STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES	Zoll Medical Corp	1994-12-28	152	7
K934016	POWERCHARGER	Zoll Medical Corp	1994-10-18	426	0
K931787	ZOLL PD 5300	Zoll Medical Corp	1993-10-15	186	0
K932028	PD-1400 PACER/DEFIBRILLATOR	Zoll Medical Corp	1993-10-08	165	0
K931803	5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES	Zoll Medical Corp	1993-10-08	179	0
K931804	ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO	Zoll Medical Corp	1993-10-08	179	0
K931805	ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT	Zoll Medical Corp	1993-10-08	179	0
K932931	D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT	Zoll Medical Corp	1993-10-07	113	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