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

ILJ — Predicate Candidate Screening

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

38 daysmedian FDA review time

329 days90th percentile

73clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K110994	PARKER 500	Arjohuntleigh, Inc.	2011-07-06	89	0
K082951	IMMERSION HYDROBATH	Arjo Hospital Equipment AB	2009-04-08	187	0
K052479	MBATH 1000 (60)	Enneking Medical, Inc.	2006-01-26	139	0
K040772	PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM	Penner Manufacturing, Inc.	2004-04-05	10	10
K012061	SUPERIOR BATH, MODEL 6300	Penner Manufacturing, Inc.	2001-07-19	17	0
K012057	CASCADE BATH, MODEL 6900	Penner Manufacturing, Inc.	2001-07-19	17	0
K001079	RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO	Arjo, Inc.	2000-05-01	27	0
K993872	VANNA BATHING SYSTEM	Vancare, Inc.	2000-02-16	93	0
K992779	A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM	Medi-Man Rehabilitation Products, Inc.	2000-01-13	148	0
K991184	HYDROTONE-THERMAL CAPSULE SYSTEM	Nats Corp.	1999-06-23	76	0
K980909	VICHY SHOWER	Bouvier Hydro, Inc.	1998-08-11	154	0
K980920	EQUINOXE	Bouvier Hydro, Inc.	1998-07-16	128	0
K974321	HYDROTONE	North American Technical Services Corp.	1998-06-22	217	0
K980033	FERNO HEALTHCARE RECLINE-A-BATH 2	Ferno-Washington, Inc.	1998-04-21	106	0
K980769	WINDMERE MODEL DS-2 FOOT BATH	Windmere Corp.	1998-03-27	28	0
K971593	SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 L	The Silcraft Corp.	1998-02-26	301	0
K971592	XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM	The Silcraft Corp.	1998-02-26	301	0
K964926	BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIG	Joerns Healthcare, Inc.	1997-11-03	329	0
K952442	FREEDOM BATH	Grand Traverse Technologies	1995-11-02	161	0
K930665	CENTURY BATHING SYSTEM	Arjo-Century, Inc.	1995-08-28	930	0
K930820	AQUADYNE	Aquatherapy Systems, Inc.	1994-11-09	630	0
K930821	THERA-FIT	Aquatherapy Systems, Inc.	1994-11-09	630	0
K925195	MALIBU BATHING SYSTEM	Medi-Man Rehabilitation Products, Inc.	1994-10-17	732	0
K925193	AQUACISER II	Aquaciser, Inc.	1994-08-26	680	0
K930624	SANITAS WHIRPOOL BATHING SYSTEM	Dutton-Lainson Co.	1994-07-01	508	0
K930096	NO CROSS CONTAM HYDROTHERAPY TANK LINER	Land and Sky Mfg., Inc.	1994-06-30	538	0
K923637	ARJO-CENTURY ARM AND LEG TANK SYSTEM	Arjo-Century, Inc.	1993-02-12	206	0
K923617	FULL MOVEMENT THERAPY SYSTEMS	Arjo-Century, Inc.	1992-11-09	111	0
K923159	ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS	Arjo-Century, Inc.	1992-08-06	38	0
K922160	AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS	Aquamotion, Inc.	1992-06-19	43	0
K914125	FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403	Ferno	1991-10-25	42	0
K911758	AMISH COUNTRY SPA	Fox Pool Corp.	1991-10-02	167	0
K911551	SHOWER MINI RD-7 SANITARY WASHER	Aiex USA , Ltd.	1991-09-06	151	0
K905599	JETTA JR. HYDRO MASSAGE	Jetta Products, Inc.	1991-03-26	103	0
K910607	PACIFIC MARQUIS SPA	Marquis International , Ltd.	1991-02-21	9	0
K904106	SPA SHELL	Century Manufacturing Co.	1990-09-18	12	0
K902603	LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH	Unique Bathing Supplies, Inc.	1990-06-29	17	0
K890548	AQUACISER SYSTEM	Aquaciser, Inc.	1989-02-13	10	0
K890308	HYDROTONE I	Hydrotonics Therapy Corp.	1989-01-31	8	0
K883187	SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM	Intl. Health Technology, Inc.	1988-10-27	91	0
K883308	PARKER BATHING SYSTEM	Mid-Canada Medical	1988-09-22	48	0
K880355	MODEL 938 BATHING SYSTEM	Ferno Ille-Forge	1988-02-16	21	0
K872327	WHIRLPOOL AERATOR WB700, WB800, WB900, WB975	Associated Mills, Inc.	1987-09-04	79	0
K864721	CRYOTHERM	Grimm Scientific Industries, Inc.	1987-02-04	63	0
K861218	AQUA ARK, IMMERSION HYDROBATH	Aqua Ark, Inc.	1986-04-18	18	0
K854861	SETMA HYGIA BATH MODEL ST 7200	Setma, Inc.	1986-01-03	29	0
K854263	SETMA FHT, MODEL ST 8130	Setma, Inc.	1985-11-13	21	0
K853163	SETMA VHT	Setma, Inc.	1985-11-05	98	0
K844064	MEDO BUBBLE BATH MA-80, 400, 600 & 700	Medo U.S.A., Inc.	1985-01-23	97	0
K842941	MULTIPLE PLANETAMED;PLANETA HYDROMASS	Planeta Hausgeraete KG	1984-08-03	9	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