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

INN — Predicate Candidate Screening

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

25 daysmedian FDA review time

185 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K945650	SPIFFY	Thames Valley Children'S Centre	1994-12-19	32
K942397	THERADAPT HIGHCHAIR/STROLLER INSERT	Theradapt Products, Inc.	1994-06-22	34
K930520	THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR	Theradapt Products, Inc.	1993-03-24	50
K923753	ABLE GENERATION THERAPY TILT BENCH	The Able Generation, Inc.	1993-01-29	185
K923752	ABLE GENERATION PLAY CHAIR	The Able Generation, Inc.	1993-01-29	185
K923750	ABLE GENERATION BOOSTER CHAIR	The Able Generation, Inc.	1993-01-29	185
K923095	KAYE MODEL KIAO PELVIC/THIGH STABILIZER	Kaye Products, Inc.	1992-07-21	26
K922061	CHAIR, ADJUSTABLE, MECHANICAL	Kaye Products, Inc.	1992-05-26	22
K921272	ACTIVITY CHAIR	Rifton Equipment For the Handicapped	1992-04-07	21
K904069	BRODA NURSING CARE CHAIR	Broda Ent., Inc.	1990-09-17	13
K902951	SHOWER-A-WAY	Tri-S-Sales and Mfg.	1990-07-25	20
K902600	THE COMPANION NON-ELECTRIC LIFT CHAIR	Innovative Medical Engineering, Inc.	1990-06-21	9
K896814	TOI-LIFT	Mill-Tech Ent., Inc.	1990-02-20	78
K894767	CORNER SEAT	Canadian Posture and Seating Centre, Inc.	1990-01-17	175
K882090	HIP SAVER	Pride Health Care, Inc.	1988-05-26	7
K874060	CONVERTA-LITTER	Camtec	1987-12-10	66
K862957	MERIVAARA GERIATRIC CHAIR MODEL 455	Global Medical Prods, Inc.	1986-08-21	15
K862885	CAR SEAT	Mednet, Inc.	1986-08-14	23
K862883	ORTHOPEDIC SEATS	Mednet, Inc.	1986-08-14	23
K841691	SPLIT SEAT POSITIONING CHAIR	Maddak, Inc.	1984-05-09	16
K832511	RECLINING WHEELS	Reclining Wheels	1983-08-31	35
K823277	THE PROGRESSIVE CHAIR	Progressive Productions , Ltd.	1982-12-13	40
K821651	E-Z UP ARTHERAPEDIC CHAIR	Medical Device Consultants, Inc.	1982-06-24	20
K812399	CHAIR, ADJUSTABLE, MECHANICAL	Kaye Products, Inc.	1981-09-14	25
K812347	RAISED CHAIR W/FOOT PLATFORM	Fred Sammons, Inc.	1981-09-11	24
K811484	SEATING STOOLS	Fred Sammons, Inc.	1981-06-16	21

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