Atlas FDA

INX

28 FDA 510(k) clearances · Product code

77 daysmedian time to decision
279 days90th percentile
28clearances measured

FDA profile

Official device name
Bed, Air Fluidized
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5160
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2019: 15 · 2022: 18 · 2023: 60 · 2024: 80 · 2025: 173 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HOME CARE BEAD BED (K972176)Kinetic Concepts, Inc.1998-01-16
CLINITRON RITE-HITE (K964223)Hill-Rom, Inc.1997-05-28
CLINITRON ELEXIS (K943385)Ssi Medical Services, Inc.1995-02-27
CLINITRON AT HOME AIR FLUIDED THERAPY (K942184)Ssi Medical Services, Inc.1995-02-07
X-20 AIR SUPPORT BED (K931168)American Life Support Technology, Inc.1994-02-17
LOW AIR LOSS MATTRESS, MODIFICATION (K934689)Cardio Systems, Inc.1994-02-02
DYLNAMEDICS A.S.A.P. (K924973)Dynamedics, Inc.1993-10-15
COMFORT CARE LOW AIR LOSS THERAPY BED (K926402)Ch Administration, Inc.1993-03-24
REM-AIR (K924686)Mellenair Ent., Inc.1993-02-12
CLINITRON C-II (K920112)Support Systems Intl.1992-01-24
SMITH AND DAVIS PRESSURE THERAPY SYSTEM (K913654)Smith & Davis Mfg. Co.1991-11-22
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (K911246)The Medical Group, Inc.1991-06-06
DERMATEK 4000 (K911057)Anacom General Corp.1991-04-05
STAGE IV, AIR-FLUIDIZE BED (K904008)Unique Flotation Systems, Inc.1990-10-10
SUPERCAIR (K890523)Ssi Medical Services, Inc.1989-02-10
TASSI MK2 (K884835)Therapy Air Support Systems, Inc.1988-12-07
MICROAIR FLUIDIZED AIR BED (K884529)Gsi Development Co.1988-11-18
FLUIDAIR (K881917)Kinetic Concepts, Inc.1988-11-14
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM (K881705)Surgi-Med, Inc.1988-07-13
MODIFIED AIR FLUIDIZED BED, KINAIR (K880340)Kinetic Concepts, Inc.1988-02-16
SKYTRON MODEL 610-2 (K870045)Skytron, Div. the Kmw Group, Inc.1987-02-04
AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS (K852036)Air Plus, Inc.1985-09-05
CLINITRON AIR FLUIDIZED SUPPORT J-101UD (K843389)Uhi Corp.1984-09-05
APOLLO AIR FLUIDIZED BED (K842987)Apollo Fluid Dynamics1984-08-02
MED-OPEDIC SLEEP SYSTEM (K834344)Bemco Mattress Co.1984-01-17
CLINITRON AIR FLUIDIZED SUPPORT SYSTEM (K813584)Uhi Corp.1982-01-12
NEO-WAVE SYSTEM (K810543)Gaymar Industries, Inc.1981-03-06
MEDISCUS AIR BED (K760712)Hsi Products, Inc.1976-11-24

Track INX automatically

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