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

FNL — Predicate Candidate Screening

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

85 daysmedian FDA review time

213 days90th percentile

70clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K202964	iBed Wireless with iBed Mobile	Stryker Corporation	2021-06-18	261	0
K103536	IBED WIRELESS WITH IBED AWARENESS	Stryker Corporation	2010-12-16	15	0
K982783	VAIL 1000 ENCLOSED BED	Vail Products, Inc.	1998-10-05	59	1
K974296	MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC B	Invacare Corp.	1998-01-06	50	0
K974254	BENEFIT B3--- SERIES	M.C. Healthcare Products, Inc.	1997-12-16	33	0
K972115	VOLKER HOSPITAL BED, MODEL K960	Volker Healthcare, Inc.	1997-08-29	85	0
K971546	SOMA 900 TRANSPORT BED	Nova Technologies, Inc.	1997-07-10	73	0
K963622	VAIL 2000 ENCLOSED BED	Vail Products, Inc.	1997-05-07	239	1
K963589	VAIL 3000 BED ENCLOSURE	Vail Products, Inc.	1997-04-21	224	0
K962942	TOTALCARE	Hill-Rom, Inc.	1997-02-03	189	0
K963701	SOMA SAFE ENCLOSURE	Nova Technology Corp.	1997-01-24	130	0
K964246	NOVABED PATIENT TRANSFER SYSTEM	Nova Technology Corp.	1997-01-22	90	0
K964515	ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001	M.C. Healthcare Products, Inc.	1996-12-31	76	0
K962250	CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED	Carroll Healthcare, Inc.	1996-10-21	131	0
K962763	2000 MODULAR THIRTY-NINE	Equi-Tron Mfg., Inc.	1996-10-07	83	0
K951514	SSC MODEL 4000 SERIES	Ssc Medical Products, Inc.	1996-03-06	338	0
K951735	JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL	Joerns Healthcare, Inc.	1995-08-18	126	1
K951161	MC ACCLAIM Q6000 BED	Janco Consulting Services	1995-05-09	56	0
K945042	ELITE 3 LOW AIR LOSS BED	Pegabus Egerton, Ltd.	1995-03-16	153	0
K946208	VOLKER NURSING BED MODEL 2080E & 2090E	Volker Healthcare, Inc.	1995-03-14	83	0
K946149	STRYKER AGILITY INTENSIVE CARE BED	Stryker Medical	1995-03-14	88	0
K945664	BARIKARE PLUS	Kinetic Concepts, Inc.	1995-02-16	91	0
K935837	AIRHYTHM HEALTHCARE BED	Healthcare Designs	1994-06-21	196	0
K934090	S.S.C. MEDICAL MODEL 5000 SERIES BED	Super Sagless Corp.	1994-02-09	169	0
K932663	MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES	Medline Industries, Inc.	1993-11-30	181	0
K930703	ADJUSTABLE BED	Maxwell Products, Inc.	1993-11-22	285	0
K931581	GLENN BED	Kinetic Concepts, Inc.	1993-10-21	205	0
K931482	STRYKER MPS ACUTE CARE BED	Stryker Corp.	1993-09-09	169	0
K926435	COMFORTADE	Sensible Products	1993-08-19	239	0
K930234	FLH1768M SERIES HOSPITAL BED	Bertec Medical, Inc.	1993-07-27	189	0
K925576	BURKE BARIATRIC TREATMENT SYSTEM II	Burke Mobility Products	1993-06-04	213	0
K925534	FULL/SEMI ELECTRIC HOME CARE BED	Ivacare Corp.	1993-05-12	191	0
K922352	THE ADVANCE SERIES FROM HILL-ROM	Hill-Rom, Inc.	1992-10-13	147	0
K915437	CRITICAL CARE HOSPITAL BED (ICU/CCU)	Hill-Rom, Inc.	1992-06-11	198	0
K911893	EASY ACCESS BED	Willis Therapeutic Innovations, Inc.	1991-11-22	207	0
K903904	SERIES 2000 ADJUSTABLE BED	Equi-Tron Mfg., Inc.	1990-10-12	50	0
K902183	S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED	Super Sagless Corp.	1990-07-11	58	0
K900151	INVACARE EXTENDED CARE NURSING HOME BED	Invacare Corp.	1990-06-18	158	0
K894296	PREMISE SERIES BED	Batesville American Mfg. Co.	1989-09-22	92	0
K893745	THE INDEPENDENT CARE UNIT	The Water Carriage Co., Inc.	1989-09-22	127	0
K890845	PREMISE SERIES BED	Batesville American Mfg. Co.	1989-06-15	114	0
K890293	AIDE-A-PATIENT (NURSING HOME BED)	Morton Metalcraft Co.	1989-04-07	78	0
K890426	CONSUMMATE AIR THERAPY BED	Health Products, Inc.	1989-04-05	69	0
K881960	MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74	Med Service, Inc.	1988-11-01	175	0
K883463	HOSPITAL BED CLOTHING CRADLE	Commercial Products & Engineering Co.	1988-09-19	35	0
K881844	MAGNUM 800(TM) MANAGEMENT SYSTEM	The Medical Group, Inc.	1988-07-14	73	0
K881782	MSI 4000 SERIES BED	Med Service, Inc.	1988-07-12	77	0
K881963	MSI 3002 SERIES BED	Med Service, Inc.	1988-06-28	49	0
K881965	MSI 5000 SERIES BED	Med Service, Inc.	1988-05-31	21	0
K881027	MSI 2002 SERIES BED	Med Service, Inc.	1988-05-26	77	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