Atlas FDA

IOQ

57 FDA 510(k) clearances · Product code

70 daysmedian time to decision
265 days90th percentile
57clearances measured

FDA profile

Official device name
Bed, Flotation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5170
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2021: 56 · 2022: 22 · 2023: 111 · 2024: 392 · 2025: 143 · 2026: 93
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
Hill-Rom Wireless Connectivity Module (K143414)Hill-Rom2015-03-10
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 (K122473)Hill-Rom2013-06-03
NURSE'S AID PATIENT ROTATION SYSTEM (K973624)Air Med Assist Products1998-01-21
HYDROTEC LOW AIR LOSS THERAPY BED (K970363)Apex Metal, Inc.1997-11-17
AIRTEC2 LOW AIR LOSS THERAPY BED (K970364)Apex Metal, Inc.1997-11-17
TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (K970636)Hill-Rom, Inc.1997-08-26
SILKAIR LOW AIRLOSS THERAPY (K964873)Hill-Rom, Inc.1997-07-03
FLEXICAIR EXLIPSE PLUS (K970295)Hill-Rom, Inc.1997-05-16
TOTAL CONTACT SEAT RIPPLE SYSTEM (K943433)Numotech, Inc.1995-07-31
FLEXICAIR EXLIPSE (K951001)Hill-Rom, Inc.1995-06-27
DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE (K945729)Hill-Rom, Inc.1995-02-27
CLENSICAIR LOW AIRLOSS HYDROTHERAPY (K941610)Support Systems Intl.1995-02-10
I-5000 (K940662)Support Systems Intl.1994-06-15
THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (K931594)Medical Device Inspection Co., Inc.1993-12-21
PRISM (K932480)Bio Clinic Co.1993-07-21
ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE (K926189)Bio Clinic Co.1993-06-24
MICROAIR PUP (K925694)Gsi Medical Systems1993-03-24
MICROAIR TURN-Q (K926456)Gsi Development Co.1993-03-24
AKROTECH 4000 (K923977)Lumex, Inc.1993-02-12
RESTCUE CC (K922973)Support Systems Intl.1992-07-30
ORTHODERM CONVERTIBLE II (K922140)Bio Clinic Co.1992-05-27
HAZEL II (K921768)Kinetic Concepts, Inc.1992-04-29
FLEXICAIR LOW AIRLOSS THERAPY UNIT (K920382)Support Systems Intl.1992-04-07
B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT (K915671)Progressive Medical Technology, Inc.1992-01-13
TURBO (K912854)Kinetic Concepts, Inc.1991-12-20
MICROAIR 3500 (K914674)Gsi Development Co.1991-11-22
CLA-1400 SYSTEM (K914851)Gaymar Industries, Inc.1991-11-13
HAZEL (K912855)Kinetic Concepts, Inc.1991-09-06
TASSI MK3 (TURNAIR) (K910851)Therapy Air Support Systems, Inc.1991-05-15
COMFORT-AIRE (K905126)Advanced Air Dynamics, Inc.1990-12-19
BIO MEDX AIR FLOTATION SYSTEM (K905156)Bio Clinic Co.1990-11-27
STAGE ZERO AIR FLOTATION BED (K905053)Lake Medical Products, Inc.1990-11-26
STAGE III (K903659)Unique Flotation Systems, Inc.1990-09-17
MARK IV FLOATATION THERAPY BED (K901890)Hydrothermic Floatation Systems, Inc.1990-05-07
PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (K901295)The Medical Group, Inc.1990-03-30
SYSTEM 2500 MEDICAL WATERBED (K894723)Dermanetics Corp.1989-08-17
ORTHODERM CONVERTIBLE (K894353)Health Products, Inc.1989-08-09
M.F.S. LOW AIR LOSS PULSATING BED (K893801)Medical Flotation Systems, Inc.1989-07-25
AEROMAT MRS-1000 (K893614)Integrated Therapy Products, Inc.1989-06-22
FLUIDIZED AIR BED (K893708)Gsi Development Co.1989-06-22
SYSTEM 3000 FLUIDIZED AIR BED (K890935)Dermanetics Corp.1989-03-15
ADD-ON TO CRITICAL PATIENT CARE BED (K882177)Cardio Systems, Inc.1988-12-01
PEDIATRIC HOSPITAL BED (K881843)The Medical Group, Inc.1988-10-26
SMI 3000 AIRBED (K883192)Smi Patientcare, Inc.1988-10-26
ULTRAFLOTATION BED (K882607)Medical Flotation Systems, Inc.1988-10-14
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (K882229)Biologics Intl., Inc.1988-08-16
DERMGARD SYSTEM 800 AND 900 (K880486)Dermgard, Inc.1988-02-22
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE (K875321)Kinetic Concepts, Inc.1988-01-27
DECUB-I-CON 800 AND 900 SYSTEM (K871614)Wholesale Medical Supply, Inc.1987-08-21
SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269 (K871368)Schell B.V.1987-05-01
ROTATION AIR FLUIDIZED BED/DELTA (K864232)Kinetic Concepts, Inc.1986-12-16
FLEXICAIR (K863047)Ssi Medical Services, Inc.1986-09-05
WATER FLOATION BED 800/TC/H (K840881)Western Medical, Ltd.1984-07-18
HOME CARE WATER FLOTATION BED HC4/TC/H (K840882)Western Medical, Ltd.1984-07-18
CALM WATER FLOTATION HOSPITAL BED (K840697)Calm Handicap Supplies, Inc.1984-02-27
NEO-FLOAT NEONATAL FLOTATION SYS & RHYT (K832829)Clinical Data Instruments, Inc.1983-10-04
FLOTATION THERAPY BED (K771264)Aquarius Medical Services1977-08-02

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Every clearance here is in the API, with alerts when new ones post.