Atlas FDA

FNL

70 FDA 510(k) clearances · Product code

85 daysmedian time to decision
213 days90th percentile
70clearances measured

FDA profile

Official device name
Bed, Ac-Powered Adjustable Hospital
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5100
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 1,377 · 2022: 1,118 · 2023: 2,185 · 2024: 2,327 · 2025: 2,790 · 2026: 1,876
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
iBed Wireless with iBed Mobile (K202964)Stryker Corporation2021-06-18
IBED WIRELESS WITH IBED AWARENESS (K103536)Stryker Corporation2010-12-16
VAIL 1000 ENCLOSED BED (K982783)Vail Products, Inc.1998-10-05
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (K974296)Invacare Corp.1998-01-06
BENEFIT B3--- SERIES (K974254)M.C. Healthcare Products, Inc.1997-12-16
VOLKER HOSPITAL BED, MODEL K960 (K972115)Volker Healthcare, Inc.1997-08-29
SOMA 900 TRANSPORT BED (K971546)Nova Technologies, Inc.1997-07-10
VAIL 2000 ENCLOSED BED (K963622)Vail Products, Inc.1997-05-07
VAIL 3000 BED ENCLOSURE (K963589)Vail Products, Inc.1997-04-21
TOTALCARE (K962942)Hill-Rom, Inc.1997-02-03
SOMA SAFE ENCLOSURE (K963701)Nova Technology Corp.1997-01-24
NOVABED PATIENT TRANSFER SYSTEM (K964246)Nova Technology Corp.1997-01-22
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 (K964515)M.C. Healthcare Products, Inc.1996-12-31
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED (K962250)Carroll Healthcare, Inc.1996-10-21
2000 MODULAR THIRTY-NINE (K962763)Equi-Tron Mfg., Inc.1996-10-07
SSC MODEL 4000 SERIES (K951514)Ssc Medical Products, Inc.1996-03-06
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL (K951735)Joerns Healthcare, Inc.1995-08-18
MC ACCLAIM Q6000 BED (K951161)Janco Consulting Services1995-05-09
ELITE 3 LOW AIR LOSS BED (K945042)Pegabus Egerton, Ltd.1995-03-16
VOLKER NURSING BED MODEL 2080E & 2090E (K946208)Volker Healthcare, Inc.1995-03-14
STRYKER AGILITY INTENSIVE CARE BED (K946149)Stryker Medical1995-03-14
BARIKARE PLUS (K945664)Kinetic Concepts, Inc.1995-02-16
AIRHYTHM HEALTHCARE BED (K935837)Healthcare Designs1994-06-21
S.S.C. MEDICAL MODEL 5000 SERIES BED (K934090)Super Sagless Corp.1994-02-09
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES (K932663)Medline Industries, Inc.1993-11-30
ADJUSTABLE BED (K930703)Maxwell Products, Inc.1993-11-22
GLENN BED (K931581)Kinetic Concepts, Inc.1993-10-21
STRYKER MPS ACUTE CARE BED (K931482)Stryker Corp.1993-09-09
COMFORTADE (K926435)Sensible Products1993-08-19
FLH1768M SERIES HOSPITAL BED (K930234)Bertec Medical, Inc.1993-07-27
BURKE BARIATRIC TREATMENT SYSTEM II (K925576)Burke Mobility Products1993-06-04
FULL/SEMI ELECTRIC HOME CARE BED (K925534)Ivacare Corp.1993-05-12
THE ADVANCE SERIES FROM HILL-ROM (K922352)Hill-Rom, Inc.1992-10-13
CRITICAL CARE HOSPITAL BED (ICU/CCU) (K915437)Hill-Rom, Inc.1992-06-11
EASY ACCESS BED (K911893)Willis Therapeutic Innovations, Inc.1991-11-22
SERIES 2000 ADJUSTABLE BED (K903904)Equi-Tron Mfg., Inc.1990-10-12
S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED (K902183)Super Sagless Corp.1990-07-11
INVACARE EXTENDED CARE NURSING HOME BED (K900151)Invacare Corp.1990-06-18
PREMISE SERIES BED (K894296)Batesville American Mfg. Co.1989-09-22
THE INDEPENDENT CARE UNIT (K893745)The Water Carriage Co., Inc.1989-09-22
PREMISE SERIES BED (K890845)Batesville American Mfg. Co.1989-06-15
AIDE-A-PATIENT (NURSING HOME BED) (K890293)Morton Metalcraft Co.1989-04-07
CONSUMMATE AIR THERAPY BED (K890426)Health Products, Inc.1989-04-05
MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74 (K881960)Med Service, Inc.1988-11-01
HOSPITAL BED CLOTHING CRADLE (K883463)Commercial Products & Engineering Co.1988-09-19
MAGNUM 800(TM) MANAGEMENT SYSTEM (K881844)The Medical Group, Inc.1988-07-14
MSI 4000 SERIES BED (K881782)Med Service, Inc.1988-07-12
MSI 3002 SERIES BED (K881963)Med Service, Inc.1988-06-28
MSI 5000 SERIES BED (K881965)Med Service, Inc.1988-05-31
MSI 2002 SERIES BED (K881027)Med Service, Inc.1988-05-26
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED (K875037)Stryker Corp.1988-02-11
MSI 9000 SERIES BED (K873291)Med Service, Inc.1987-12-30
PARAGON 9000 TILT AND TURN BED (K872923)Surgi-Med, Inc.1987-10-14
PARAGON 8500 CARDIO-PULMONARY BED (K872924)Surgi-Med, Inc.1987-10-09
MEGABED 1000 (K872925)Surgi-Med, Inc.1987-09-15
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) (K864186)Hill-Rom, Inc.1986-11-13
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS (K864172)Hill-Rom, Inc.1986-11-13
EVEREST & JENNING SERIES 5000 MODULAR BED (K854832)Carrom Healthcare, Inc.1986-02-04
CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM (K854937)Carrom Healthcare, Inc.1986-02-04
EVEREST & JENNINGS TRADITION-STANDARD BED L109684& (K854867)Carrom Healthcare, Inc.1986-02-04
CENTERCOM CONTROL (K853270)Carrom Healthcare, Inc.1985-11-13
STRYKER 988 ICU BED (K852674)Stryker Corp.1985-07-16
MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES (K851551)Daun International, Inc.1985-05-08
KINAIR, LOW AIR LOSS BED (K843781)Kinetic Concepts, Inc.1985-01-28
PNEUMATIC/ELECTRIC/HYDRAULIC BED (K831821)G.W. Healthcare, Inc.1983-08-08
HEALTHCARE MODEL #175/176 BED SERIES (K830559)G.W. Healthcare, Inc.1983-03-09
NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS (K821185)Dase Co.1982-09-14
LIC TURNOVER BED (K811897)Century Manufacturing Co.1981-07-28
BED, PARAPLEGIC (K790049)Wayne V. Kirkman1979-02-27
TILT TYPE AC POWERED HOSPITAL BED (K780371)Medical Specialty Products, Inc.1978-04-10

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