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

DRO — Predicate Candidate Screening

84 FDA 510(k) clearances under this product code; the 50 most recent screened below.

88 daysmedian FDA review time

235 days90th percentile

84clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K012218	LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECT	The Ludlow Company LP	2001-10-12	88	8
K012404	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	Katecho, Inc.	2001-10-12	74	0
K000660	ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20	Medical Data Electronics	2000-03-28	29	0
K983196	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	Tz Medical, Inc.	1999-09-15	369	1
K983232	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPAR	Tz Medical, Inc.	1999-09-15	366	0
K974034	PORTABLE INTENSIVE CARE UNIT	Medical Research Laboratories, Inc.	1998-03-02	130	3
K962547	CARDIOSERV P	Marquette Electronics, Inc.	1997-03-06	251	0
K963120	RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM	Marquette Electronics, Inc.	1997-02-28	200	0
K961138	ESORT II + 400 SERIES MONITOR	Medical Data Electronics	1996-12-10	264	0
K950856	ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000,	Zoll Medical Corp	1995-12-29	305	0
K951593	LIFEPAK 11	Physio-Control Corp.	1995-12-29	267	1
K950483	HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR	Hewlett-Packard Co.	1995-05-22	108	0
K926175	K-DEFIB/PACE CARBON ELECTRODE	Katecho, Inc.	1993-04-15	128	0
K915757	MODELS M1722A, M1723A, M1724A DEFIBRILLATORS	Hewlett-Packard Co.	1992-07-30	220	0
K915328	GEL-TAC	Katecho, Inc.	1992-06-29	216	0
K914955	K-DEFIB/PACE ELECTRODE	Katecho, Inc.	1992-05-14	191	0
K912599	QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC	Physio-Control Corp.	1991-09-11	93	0
K911956	ZOLL PD-1400 PACER/DEFIBRILLATOR	Zmi Corp.	1991-07-31	90	0
K910661	MODEL 205 SHOCK-TRODE	Cardiotronics, Inc.	1991-05-02	78	0
K903437	DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER	Keller Medical Specialties Products, Inc.	1990-11-16	108	0
K894492	NKA MODEL SEC-3102 CARDIAC STIMULATOR	Nihon Kohden America, Inc.	1989-12-20	155	0
K894588	DEFIB/PACING PADS	Conmedcorp	1989-10-26	94	0
K895729	R2 PACE PAD, MODEL 480	Darox Corp.	1989-10-12	17	1
K895728	R2 PACE ADAPTOR CABLE, MODEL 196	Darox Corp.	1989-10-12	17	0
K885166	ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES	Zmi Corp.	1989-05-01	139	0
K885171	MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE	Andover Medical, Inc.	1989-01-12	30	0
K880932	MRL PACETTE, 450SLL	Medical Research Laboratories, Inc.	1988-12-16	284	0
K884532	TRIAD-EP II, PUSHBUTTON, CABLE INPUT	Cardiotronics, Inc.	1988-11-18	21	0
K884530	TRIAD-EP II, PLATE INPUT	Cardiotronics, Inc.	1988-11-17	20	0
K883178	TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE	Cardiotronics, Inc.	1988-11-09	105	0
K883304	TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY	Cardiotronics, Inc.	1988-11-09	98	0
K883523	TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE	Cardiotronics, Inc.	1988-10-06	50	0
K883121	QUIK-PACE II ELECTRODES	Physio-Control Corp.	1988-09-20	56	0
K882338	MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE	Cardiotronics, Inc.	1988-08-30	85	0
K883375	MODEL #918 MULTI-PADS	Cardiotronics, Inc.	1988-08-30	21	0
K882168	EXTERNAL PACEMAKER 2000 (EP2000)	Unomed, Inc.	1988-08-19	87	0
K880936	TRIAD-EP	Cardiotronics, Inc.	1988-07-18	133	0
K874447	DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC	Medac, Inc.	1988-01-27	91	0
K871751	QUIK-PACE NONINVASIVE PACEMAKER	Physio-Control Corp.	1987-12-29	235	0
K874090	300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER	Medac, Inc.	1987-12-15	69	0
K873402	ZOLL NTP-1200 PACER/DEFIBRILLATOR	Zmi Corp.	1987-11-23	91	0
K872778	PACESTART	Pacific Rim Engineering & Mfg.	1987-11-04	113	0
K872368	MODIFIED VERSA STIM ELECTRODE LINE	Conmedcorp	1987-09-18	92	0
K872012	LECTEC NON-INVASIVE PACING ELECTRODE	Lectec Corp.	1987-06-29	34	0
K871971	MODIFIED PACE*AID MODEL 53	Cardiac Resucitator Corp.	1987-06-24	34	0
K871538	STAT-PAD (TM)	Cardiac Resucitator Corp.	1987-06-24	65	0
K871569	MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR	Cardiac Resucitator Corp.	1987-06-08	45	0
K871176	PACE 10 NON-INVASIVE EXTERNAL PACEMAKER	Medac, Inc.	1987-04-23	30	0
K864985	DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE	Medac, Inc.	1987-03-10	78	0
K864989	ETP 180A NON-INVASIVE EXTERNAL PACEMAKER	Medac, Inc.	1987-03-03	71	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