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

IMJ · Predicate Candidate Screening

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

106 daysmedian FDA review time

268 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252963	BTL-899TT	BTL Industries, Inc.	2026-06-12	268	0
K250376	ViVY	Viatherm Therapeutics, LLC	2025-11-05	268	0
K243112	Curapuls 670	Enraf-Nonius, B.V.	2025-06-25	268	0
K223620	Reprieve by RegenesisTM	Regenesis Biomedical, Inc.	2023-05-24	170	0
K182363	BTL-703	BTL Industries, Inc.	2019-01-24	147	0
K173300	ViaTherm BOOST	Viatherm Therapeutics, LLC	2018-05-01	196	0
K162240	ProMedTek Model C1400 Shortwave Diathermy Device	Promedtek, Inc.	2016-11-17	100	0
K161862	ThermoPro	Zimmer Medizinsysteme GmbH	2016-11-14	131	0
K153456	Megapulse III Shortwave Diathermy	Accelerated Care Plus	2016-06-14	196	0
K131926	THERMOPULSE	Ibramed Equipamentos Medicos	2014-07-24	393	0
K131899	SW-THERM	Shenzhen Dongdixin Technology Co., Ltd.	2014-03-14	262	0
K121123	BIOFUSIONARY BEBE	Rocky Mountain Biosystems, Inc.	2014-03-10	696	0
K120093	BTL ELITE	BTL Industries, Inc.	2012-10-05	267	0
K083433	INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIA	Chattanooga Group	2009-03-18	118	1
K042554	AUTO THERM 390, MODEL ME 390	Mettler Electronics Corp.	2004-10-08	18	0
K030382	SELITHERM, MODEL C100	Selicor, Inc.	2003-04-01	55	0
K022846	SW-180 SHORTWAVE THERAPY UNIT	Ito Co., Ltd.	2003-01-28	154	0
K022458	AUTO*THERM 395, MODEL ME 395	Mettler Electronics Corp.	2002-09-26	62	0
K020227	SELICOR, MODELS A100 & D100	Selicor, Inc.	2002-07-30	189	0
K973732	MEGAPULSE II	Pti	1998-01-23	115	0
K964083	ULTRATHERM (908)	Sie-Med, Inc.	1997-04-03	174	0
K962243	VASOTHERM	Ehti Medical Corp.	1997-02-21	255	0
K962703	THEE THERMASTIM	Ehti Medical Corp.	1997-02-21	224	0
K934151	MAGNATHERM MODEL 1000 SS	Intl. Medical Electronics , Ltd.	1995-02-17	541	0
K871633	TRU-SOUND ULTRASOUND THERAPY UNIT	Tru-Trac Therapy Products, Inc.	1987-05-28	31	0
K864766	SOUNDTEK MODEL UT-4700	Soundtek, Inc.	1987-03-12	97	0
K864653	MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS	Rich-Mar Corp.	1986-12-29	31	0
K862932	THE BIO-TEK UW-II	Bio-Tek Instruments, Inc.	1986-09-25	52	0
K862589	ULTRATHERM 808 I	Elmed, Inc.	1986-08-01	25	0
K862376	NEMECTROSON MODEL 2	Nemectron Medical, Inc.	1986-07-23	29	0
K861864	MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT	I-Rep, Inc.	1986-07-14	60	0
K862469	RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC	Rich-Mar Corp.	1986-07-10	10	0
K862468	RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC	Rich-Mar Corp.	1986-07-10	10	0
K861248	CURAPULS 419 DIATHERMY UNIT	Henley Intl.	1986-05-30	58	0
K861247	CURAMED 402 DIATHERMY UNIT	Henley Intl.	1986-05-30	58	0
K852166	THERMO SHORTWAVE DIATHERMY	Zimmer Elektromedizin GmbH	1985-09-30	133	0
K850573	CURAMED 402	Fluidotherapy Corp.	1985-05-17	93	0
K844416	THERMOPULS E	Nemectron Medical, Inc.	1985-03-12	118	0
K842801	ULTRAMED 11S601	Robert Bosch Corp.	1984-08-01	15	0
K841874	MEGA PULSE THERAPY UNIT	Physio Technology, Inc.	1984-05-31	24	0
K781455	SIEMENS ULTRATHERM 708	Elmed, Inc.	1978-12-07	106	0
K781316	PULSED AND CONTINUOUS SHORTWAVE APPAR.	General Theraphysical, Inc.	1978-09-27	58	0
K781320	SHORTWAVE THERAPY APPAR. CURAMED 401	General Theraphysical, Inc.	1978-09-27	58	0
K780755	SHORTWAVE DIATHERMY MODEL 802	Birtcher Corp.	1978-05-12	4	0
K771540	MAGNATHERM 2000	Intl. Medical Electronics , Ltd.	1977-10-04	54	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