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

IOQ — Predicate Candidate Screening

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

70 daysmedian FDA review time

265 days90th percentile

57clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143414	Hill-Rom Wireless Connectivity Module	Hill-Rom	2015-03-10	102	0
K122473	TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE	Hill-Rom	2013-06-03	293	2
K973624	NURSE'S AID PATIENT ROTATION SYSTEM	Air Med Assist Products	1998-01-21	120	0
K970363	HYDROTEC LOW AIR LOSS THERAPY BED	Apex Metal, Inc.	1997-11-17	290	0
K970364	AIRTEC2 LOW AIR LOSS THERAPY BED	Apex Metal, Inc.	1997-11-17	290	0
K970636	TOTALCARE., MODULAR THERAPY SYSTEM (MTS)	Hill-Rom, Inc.	1997-08-26	187	1
K964873	SILKAIR LOW AIRLOSS THERAPY	Hill-Rom, Inc.	1997-07-03	210	0
K970295	FLEXICAIR EXLIPSE PLUS	Hill-Rom, Inc.	1997-05-16	109	0
K943433	TOTAL CONTACT SEAT RIPPLE SYSTEM	Numotech, Inc.	1995-07-31	381	0
K951001	FLEXICAIR EXLIPSE	Hill-Rom, Inc.	1995-06-27	116	0
K945729	DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE	Hill-Rom, Inc.	1995-02-27	97	0
K941610	CLENSICAIR LOW AIRLOSS HYDROTHERAPY	Support Systems Intl.	1995-02-10	316	0
K940662	I-5000	Support Systems Intl.	1994-06-15	117	0
K931594	THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM	Medical Device Inspection Co., Inc.	1993-12-21	265	0
K932480	PRISM	Bio Clinic Co.	1993-07-21	58	0
K926189	ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE	Bio Clinic Co.	1993-06-24	198	0
K925694	MICROAIR PUP	Gsi Medical Systems	1993-03-24	132	0
K926456	MICROAIR TURN-Q	Gsi Development Co.	1993-03-24	90	0
K923977	AKROTECH 4000	Lumex, Inc.	1993-02-12	189	0
K922973	RESTCUE CC	Support Systems Intl.	1992-07-30	38	0
K922140	ORTHODERM CONVERTIBLE II	Bio Clinic Co.	1992-05-27	21	0
K921768	HAZEL II	Kinetic Concepts, Inc.	1992-04-29	15	0
K920382	FLEXICAIR LOW AIRLOSS THERAPY UNIT	Support Systems Intl.	1992-04-07	68	0
K915671	B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT	Progressive Medical Technology, Inc.	1992-01-13	49	0
K912854	TURBO	Kinetic Concepts, Inc.	1991-12-20	175	0
K914674	MICROAIR 3500	Gsi Development Co.	1991-11-22	35	0
K914851	CLA-1400 SYSTEM	Gaymar Industries, Inc.	1991-11-13	16	0
K912855	HAZEL	Kinetic Concepts, Inc.	1991-09-06	70	0
K910851	TASSI MK3 (TURNAIR)	Therapy Air Support Systems, Inc.	1991-05-15	76	0
K905126	COMFORT-AIRE	Advanced Air Dynamics, Inc.	1990-12-19	35	0
K905156	BIO MEDX AIR FLOTATION SYSTEM	Bio Clinic Co.	1990-11-27	12	0
K905053	STAGE ZERO AIR FLOTATION BED	Lake Medical Products, Inc.	1990-11-26	18	0
K903659	STAGE III	Unique Flotation Systems, Inc.	1990-09-17	39	0
K901890	MARK IV FLOATATION THERAPY BED	Hydrothermic Floatation Systems, Inc.	1990-05-07	11	0
K901295	PULMONAIR 40 PATIENT MANAGEMENT SYSTEM	The Medical Group, Inc.	1990-03-30	10	0
K894723	SYSTEM 2500 MEDICAL WATERBED	Dermanetics Corp.	1989-08-17	23	0
K894353	ORTHODERM CONVERTIBLE	Health Products, Inc.	1989-08-09	26	0
K893801	M.F.S. LOW AIR LOSS PULSATING BED	Medical Flotation Systems, Inc.	1989-07-25	64	0
K893614	AEROMAT MRS-1000	Integrated Therapy Products, Inc.	1989-06-22	43	0
K893708	FLUIDIZED AIR BED	Gsi Development Co.	1989-06-22	35	0
K890935	SYSTEM 3000 FLUIDIZED AIR BED	Dermanetics Corp.	1989-03-15	19	0
K882177	ADD-ON TO CRITICAL PATIENT CARE BED	Cardio Systems, Inc.	1988-12-01	191	0
K881843	PEDIATRIC HOSPITAL BED	The Medical Group, Inc.	1988-10-26	177	0
K883192	SMI 3000 AIRBED	Smi Patientcare, Inc.	1988-10-26	90	0
K882607	ULTRAFLOTATION BED	Medical Flotation Systems, Inc.	1988-10-14	112	0
K882229	AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS	Biologics Intl., Inc.	1988-08-16	88	0
K880486	DERMGARD SYSTEM 800 AND 900	Dermgard, Inc.	1988-02-22	18	0
K875321	MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE	Kinetic Concepts, Inc.	1988-01-27	29	0
K871614	DECUB-I-CON 800 AND 900 SYSTEM	Wholesale Medical Supply, Inc.	1987-08-21	119	0
K871368	SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269	Schell B.V.	1987-05-01	24	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