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

IRT — Predicate Candidate Screening

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

154 daysmedian FDA review time

383 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K250047	bite away two	mibeTec GmbH	2025-09-12	245
K220514	bite away neo	mibeTec GmbH	2022-06-23	121
K160943	Bite Away	Riemser Pharma	2016-08-26	143
K142228	Heated Eye Pad	Digital Heat Corporation	2015-02-09	180
K133981	AVACEN 100	Avacen, Inc.	2014-08-15	232
K111273	FIR HEAT THERAPHY SYSYEMS	Shenzhen Anpan Technology Co., Ltd.	2011-11-08	188
K072534	BIO-MAT 2000	Richway Intl., Inc.	2008-02-08	154
K963887	PT-PAC PORTABLE HEATING PAD	Anthony A. Chiurco	1997-03-31	186
K963824	LI'S ITCH STOPPER	Hontech Foundation For Medical Technology	1996-12-12	80
K962195	HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3	Sunbeam Health Division	1996-11-27	173
K962252	HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4	Sunbeam Health Division	1996-11-25	166
K962038	PES HOT/COLD COMPRESS	Princeton Electronic Systems, Inc.	1996-11-13	173
K924970	FEMININE HEAT WRAP	Conair Corp.	1994-10-03	733
K925630	ELASTOPLAST HEAT PLASTER	Beiersdorf, Inc.	1994-02-25	476
K925820	ARTHRITIC HEAT WRAP	Conair Corp.	1994-02-02	442
K924800	MOSIST HEAT PAD WITH AUTOMATIC OFF	Conair Corp.	1993-10-12	383
K924799	MOIST HEAT PAD	Conair Corp.	1993-10-12	383
K924885	KING SIZE HEAT PAD	Conair Corp.	1993-10-12	379
K923396	THERMODYN	Nemectron Medical, Inc.	1993-05-26	320
K922089	PNEUMATHERM	National Pain Institute	1993-02-23	295
K915241	SPORTS HEAT WRAP	Conair Corp.	1991-12-20	37
K911195	DUNLAP HEAT PAD	Home Healthcare Products, Inc.	1991-08-12	147
K903321	SANDBOX I, SANDBOX II, SANDBOX JR.	Sandbox Ent.	1991-02-19	209
K902895	INFRASSAGE MASSAGER	Conair Corp.	1990-07-25	22
K881800	BCS NO. 1, BODY CARE SYSTEM	M & A Vertrieb, Liske Und Methling GM	1988-11-16	203
K882151	PORT-O-HEAT, MODEL 0100	Arthotronics, Inc.	1988-11-04	165
K881862	THERMO-BODY-WRAP SYSTEM	Thermo Body Wrap Systems, Inc.	1988-10-13	163
K873576	HUCHEL BODYLINER	Hans-Juergen Huchel	1988-01-19	139
K873254	THERMOWRAP, A/K/A/, THERMAL WRAP	Family Sun Tanning	1987-12-11	116
K862106	FORMOSTAR	Lmv, Liske & Methling, GmbH	1986-08-21	80
K861383	SOLEX THERAPEUTIC PAD	Intl. Diathermics Research, Inc.	1986-04-18	4
K852637	THERMO TRIM	Suntec Health & Fitness Group, Inc.	1985-11-20	153
K852604	MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK	Clairol, Inc.	1985-08-12	54
K851237	THERMOPHORE ELECTRIC FOMENTATION UNIT	Battle Creek Equipment Co.	1985-07-29	124
K841697	HYDRO-THERO PAD	Maddak, Inc.	1984-05-09	16
K841100	HP-20, 30, 40, 50 & 60	Associated Mills, Inc.	1984-03-23	10
K823301	MICROPAD	Fia Man Co.	1982-12-03	28
K821692	PASSIVE HEAT PADS	Biotone International, Inc.	1982-07-13	35
K801081	DELUXE HEAT WRAP/COLD WRAP	The Gillette Company	1980-05-14	7
K791154	THERMAL CONDITIONING SYSTEM	Acurex Aerotherm	1979-10-09	111
K790374	GILLETTE HEAT WRAP	The Gillette Company	1979-04-10	46
K770686	THERATHERM	Electro Therapeutic Devices, Inc.	1977-07-14	93

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