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

FNJ — Predicate Candidate Screening

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

37 daysmedian FDA review time

123 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K934298	KING KRIB	Noritage, Inc.	1994-01-26	146
K892877	CRADLE, HOSPITAL BED CLOTHING	Warsaw Orthopedic, Inc.	1989-06-15	57
K885241	BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT	King Mfg. Co.	1989-02-24	65
K884542	SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED	Commercial Products & Engineering Co.	1988-11-21	21
K881725	ENVIROTENT (BED)	Envirotents, Inc.	1988-11-08	200
K881961	MSI STANDARD BED MODELS: L1097-64 AND L1085-64	Med Service, Inc.	1988-11-01	175
K881964	MSI 3003 SERIES BED	Med Service, Inc.	1988-06-28	49
K881962	MSI 2005 SERIES BED	Med Service, Inc.	1988-06-03	24
K881043	FOLDING HOSPITAL COT NSN 6530-00-299-8517	Junkin Safety Appliance Co., Inc.	1988-04-12	32
K870166	PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG	George C. Kuhn	1987-03-13	58
K870310	VSID MEDICAL THREE-FOLDING BED	China National Medicines & Health Prod. I/E Corp.	1987-02-10	13
K864667	PENOX HOSPITAL BED	Penox Technologies, Inc.	1987-01-21	50
K863688	ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE	Brenner Metal Prod Corp.	1987-01-20	123
K863691	COT, FOLDING, HOSPITAL, ALUMINUM	Brenner Metal Prod Corp.	1987-01-20	123
K863694	BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS	Brenner Metal Prod Corp.	1987-01-20	123
K863685	CART, ORTHOPEDIC BED, STRYKER	Brenner Metal Prod Corp.	1987-01-15	118
K864878	ICU/CPU TRANSPORT TRAY	Orthopedic Systems, Inc.	1987-01-06	25
K864203	NESBIT EVANS NURSING HOME BED	J. Nesbit Evans & Co.	1986-11-07	11
K863748	HOSPITAL BED	Global Medical Prods, Inc.	1986-10-09	15
K861678	COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED	Sierra Corp.	1986-05-08	7
K854940	TIPS AND PADS, CANE,CRUTCH AND WALKER	Healthtech Industries, Inc.	1986-01-30	51
K854776	EVEREST & JENNINGS BED MODEL NO. L109564 & L108564	Carrom Healthcare, Inc.	1985-12-13	14
K854257	COMBO 36	Kg Engineering, Inc.	1985-11-18	27
K852890	AM FAB SIDE RAILS MODEL 5000	Am Fab, Inc.	1985-07-24	15
K851552	MERIVAARA HOSPITAL BED	Daun International, Inc.	1985-05-08	22
K840653	BERNIER ARM SUPPORT	T.C. Toll Corp.	1984-03-19	33
K832845	EGERTON TURNING & TILTING NET SUSPEN BED	Kinetic Concepts, Inc.	1983-11-28	98
K823821	SIDE RAIL PADS	Danek Medical, Inc.	1983-01-21	35
K813356	DEVICE FOR REPOSITIONING A BET PATIENT	Ali-Oop Co., Inc.	1982-02-10	75
K812600	GER 540, GER 541 MANUAL BED	G.W. Healthcare, Inc.	1981-09-23	9
K810846	SWEEN UNIVERSAL BED RAIL PADS	Sween Corp.	1981-04-17	21
K801517	BED ROCKING DEVICE	Wesler	1980-10-10	101
K792298	THE VERSA-BED	First & Ten, Inc.	1979-12-20	37
K791993	SKIL-CARE BED RAIL PADS	Skil-Care Corp.	1979-10-26	23
K791189	ECHO CARDIOGRAM PAD	Alimed, Inc.	1979-07-17	21
K772261	TRAPEZE FLOOR BASE	Med Fusion Systems, Inc.	1978-01-26	48
K772262	TRAPEZE BAR KNOCKED DOWN	Med Fusion Systems, Inc.	1978-01-26	48
K772260	TELESCOPING BEDRAILS	Med Fusion Systems, Inc.	1978-01-26	48
K760315	PAD, POLYETHER FOAM, OPEN CELL	Gaymar Industries, Inc.	1976-08-11	16

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