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

Katecho, Inc. — Predicate Candidate Screening

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

150 daysmedian FDA review time

273 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K012404	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	Katecho, Inc.	2001-10-12	74	0
K010543	KM-30 TENS ELECTRODE	Katecho, Inc.	2001-05-23	89	0
K003228	K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A	Katecho, Inc.	2000-12-14	59	1
K002806	K-DEFIB/PACE, MODEL KDP-60A	Katecho, Inc.	2000-11-21	74	0
K000870	KM-10 TENS ELECTRODE	Katecho, Inc.	2000-11-07	232	0
K993745	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80	Katecho, Inc.	2000-02-03	90	0
K991007	K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60	Katecho, Inc.	1999-08-23	150	0
K981737	K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60	Katecho, Inc.	1998-12-09	205	0
K954504	K-DEFIB/PACE PEDIATRIC ELECTRODE	Katecho, Inc.	1995-11-17	50	0
K934692	K-DEFIB/PACE PEDIATRIC ELECTRODE	Katecho, Inc.	1995-01-24	481	0
K940801	K-KLIP	Katecho, Inc.	1994-08-03	162	0
K935083	PEDIATRIC DEFIB K-PADS	Katecho, Inc.	1994-07-25	273	0
K940586	K-SNAP	Katecho, Inc.	1994-06-09	121	0
K922202	K-STIM CLEAR	Katecho, Inc.	1993-05-17	371	0
K926175	K-DEFIB/PACE CARBON ELECTRODE	Katecho, Inc.	1993-04-15	128	0
K921679	K-DISPERSE	Katecho, Inc.	1992-10-06	181	0
K915328	GEL-TAC	Katecho, Inc.	1992-06-29	216	0
K914955	K-DEFIB/PACE ELECTRODE	Katecho, Inc.	1992-05-14	191	0
K912381	LOW BACK STRIP (OR) K-BACK	Katecho, Inc.	1992-01-30	246	0
K913031	K-STIM	Katecho, Inc.	1992-01-30	205	0
K912587	K-FREE	Katecho, Inc.	1991-07-30	48	0
K900997	K-STERILE TENS ELECTRODES	Katecho, Inc.	1990-03-13	11	0
K895662	DEFIB K-PADS	Katecho, Inc.	1990-01-18	120	0
K863899	K-STIK DEFIBRILLATION PADS	Katecho, Inc.	1986-11-12	36	0
K843829	K-MESH	Katecho, Inc.	1985-06-05	247	0
K843557	K-APATITE 20-40 MESH K-APATITE 40-60	Katecho, Inc.	1984-11-30	81	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