Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

3 — Predicate Candidate Screening

1,463 FDA 510(k) clearances under this device class; the 50 most recent screened below.

78 daysmedian FDA review time

238 days90th percentile

1,463clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143714	Powerheart G5 AED	Cardiac Science Corporation	2015-05-04	126	0
K150198	CPR Dura-Padz Reusable Defibrillation Electrode with Dura-pa	Bio-Detek, Inc.	2015-05-02	93	0
K150055	OneStep Pediatric CPR Multi-Function Electrode	Bio-Detek, Inc.	2015-05-02	110	0
K142709	samaritan PAD 450P	Heartsine Technologies, Inc.	2015-03-27	186	0
K133659	HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DI	Philips Medical Systems	2015-01-23	422	0
K133239	ZOLL E SERIES	Zoll Medical Corporation, World Wide Headquarters	2015-01-16	452	0
K142430	LIFEPAK 15 monitor/defibrillator	Physio-Control, Inc.	2014-12-19	112	4
K141795	BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500	R & D Batteries, Inc.	2014-12-08	158	0
K142915	ZOLL X Series	ZOLL Medical Corporation	2014-12-03	57	0
K142803	Skintact, various other tradenames	Leonhard Lang GmbH	2014-12-02	64	2
K141231	ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY	Zeller Power Products (Battery Beast, LLC)	2014-11-25	196	0
K141774	ZOLL X SERIES	ZOLL Medical Corporation	2014-11-19	140	0
K133441	ONESTEP CPR II MULTI-FUNCTION ELECTRODE	Bio-Detek, Inc.	2014-10-10	332	0
K133484	ZOLL X SERIES	Zoll Medical Corp	2014-08-01	261	0
K133269	ZOLL X SERIES	Zoll Medical Corporation, World Wide Headquarters	2014-05-22	210	0
K131525	SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Defibtech, LLC	2014-04-24	331	0
K122758	POWERHEART G5 AED	Cardiac Science Corporation	2014-02-12	520	0
K131550	HEART SYNC	Heart Sync, Inc.	2013-12-06	191	0
K130684	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Philips Medical Systems	2013-10-18	219	1
K131494	HEART SYNC	Heart Sync, Inc.	2013-09-16	116	0
K130454	LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/	Physio-Control, Inc.	2013-08-21	180	1
K123881	HEARTSINE SAMARITAN PAD 350P	Heartsine Technologies, Inc.	2013-07-11	206	1
K130006	BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS	Cook Biotech Incorporated	2013-04-05	93	0
K130153	HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST	Philips Medical Systems	2013-03-12	49	0
K113787	DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORI	Defibtech, LLC	2013-01-04	379	0
K122459	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE	Boston Scientific Corporation	2012-12-13	122	2
K121853	DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCES	Defibtech, LLC	2012-12-13	171	0
K122839	ZOLL SUREPOWER SINGLE BAY CHARGER	ZOLL Medical Corporation	2012-12-13	87	0
K120350	EXTENDED LIFE BATTERY	Aed Battery Exchange, LLC	2012-11-01	269	0
K120406	ZOLL FULLY AUTOMATIC AED PLUS	Zoll Medical Corporation, World Wide Headquarters	2012-10-26	260	0
K122600	LIFEPAK 1000 DEFIBRILLATOR	Physio-Control, Inc.	2012-10-11	45	1
K122778	PROFEMUR Z REVISION HIP STEM	Wrightmedicaltechnologyinc	2012-10-11	30	0
K120907	ZOLL R SERIES	Zoll Medical Corporation, World Wide Headquarters	2012-09-25	183	0
K120536	HEART SYNC PEDIATRIC PHYSIO AED PAD	Heart Sync, Inc.	2012-08-06	166	0
K121544	DYNASTY BIOFOAM SHELL	Wrightmedicaltechnologyinc	2012-07-30	66	0
K121612	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH	American Medical Systems	2012-07-20	49	0
K113271	METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS	Biomet Manufacturing, Inc.	2012-05-18	196	0
K112761	ZOLL PROPAQ MD	Zoll Medical Corporation, World Wide Headquarters	2012-04-25	216	1
K112432	ZOLL X SERIES	Zoll Medical Corporation, World Wide Headquarters	2012-03-21	211	2
K110825	PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES,	Philips Medical Systems	2012-02-16	330	6
K113322	CONSERVE THIN SHELL	Wrightmedicaltechnologyinc	2012-02-03	85	0
K112080	PRESERVE HIP STEM	Wrightmedicaltechnologyinc	2011-12-28	160	0
K112150	PROFEMUR GLADIATOR HA HIP STEM	Wrightmedicaltechnologyinc	2011-11-23	119	0
K113019	PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CEN	Wrightmedicaltechnologyinc	2011-11-10	30	0
K111693	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Philips Medical Systems	2011-10-28	134	1
K112842	AMS ELEVATE PC	American Medical Systems, Inc.	2011-10-25	26	0
K111910	GLADIATOR HIP STEM	Wrightmedicaltechnologyinc	2011-10-14	101	0
K110836	CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY	Zimmer GmbH	2011-10-07	196	0
K110400	TAPERLOC COMPLETE MICROPLASTY STEM	Biomet Manufacturing Corp	2011-09-30	231	0
K103426	LITE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2011-09-14	296	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