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

INM · Predicate Candidate Screening

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

22 daysmedian FDA review time

119 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K063521	NISSIN PEDIATRIC SERIES WHEELCHAIR	Nissin Medical, Inc.	2007-02-05	75
K941738	STRYKER 5050 STRECHAIR	Stryker Medical	1994-05-06	29
K941569	CAREMOR CLINER	Winco, Inc.	1994-04-26	26
K933000	RECLINING GERI CHAIRS W/CASTERS & LAP TRAY	Winco, Inc.	1993-09-30	104
K926028	BENCHES	Theradapt Products, Inc.	1993-03-24	161
K926025	CHAIRS	Theradapt Products, Inc.	1993-03-22	159
K926054	ELD-ARONDAK CHAIR	Al'S Woodcraft, Inc.	1993-03-22	111
K926053	ELD-ARONDAK CHAIR	Alert Care, Inc.	1993-03-22	111
K924848	KAYE SCOOT-ABOUT, MODEL SB1	Kaye Products, Inc.	1993-02-12	137
K925247	STONEHEART ROLLER AID	Stoneheart, Inc.	1993-02-12	119
K922045	SHOWER CHAIRS	Medical Device Inspection Co., Inc.	1992-05-26	25
K921917	DOLOMITE ROLLATOR	Seamark Technologies	1992-05-26	33
K921752	AMBULATOR	The Anthros Medical Group	1992-05-04	21
K921817	RIFTON MOR219 19 & RIFTON MOR225 25	Rifton Equipment For the Handicapped	1992-04-29	14
K913544	DUKKI	Pin Dot Products, Inc.	1991-08-29	20
K895165	ZIGGY MEDICHAIR	Laszlo Corp.	1989-09-11	20
K884760	SHOWER CHAIR	Linido, Inc.	1988-11-30	16
K883309	MULTI-CARE CHAIR	Mid-Canada Medical	1988-09-30	56
K880986	MECHANICAL WALKER	Canhart Industries, Inc.	1988-03-14	6
K862886	KOOYCHAIR (PEDIATRIC)	Mednet, Inc.	1986-08-13	22
K851550	MERIVAARA GERIATRIC CHAIR	Daun International, Inc.	1985-07-09	84
K851548	AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS	Daun International, Inc.	1985-07-09	84
K841194	MEDICAL CHAIR, MULTIPURPOSE TAST SUPPORT	Neutral Pos-Chair Co.	1984-05-30	70
K841911	ALPHA PUSH KART	Alpha Unlimited, Inc.	1984-05-23	14
K841700	WALK & ROLL	Maddak, Inc.	1984-05-11	18
K841725	OSLO ARMCHAIR	Mondial, Inc.	1984-05-09	14
K840638	PORTABLE TRANSIT CHAIR	Poirier S.A.	1984-03-16	56
K830850	OB TRIPP TRANSPORT CHAIR	Lic-Orthion	1983-04-05	19
K823151	OB TRIPP TRANSPORT CHAIR	Orthion Corp.	1982-11-05	16
K822992	PEOPLE MOVER	Convaid Products, Inc.	1982-10-27	15
K820858	ESCORT	Amigo Sales, Inc.	1982-04-08	10
K802744	FOLDING ROLL-ABOUT CHAIR	Winco Winfield Co., Inc.	1980-11-19	16
K802745	FOLDING SHOWER-COMMODE CHAIR	Winco Winfield Co., Inc.	1980-11-19	16
K790560	ROLLCHAIR, ORTHO BUCKET SEAT	Maddak, Inc.	1979-04-10	22
K781001	CHAIRS WITH CASTORS	Orthopedic Equipment Co., Inc.	1978-06-30	15

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