Atlas FDA

FNM

102 FDA 510(k) clearances · Product code

98 daysmedian time to decision
255 days90th percentile
102clearances measured

FDA profile

Official device name
Mattress, Air Flotation, Alternating Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5550
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 47 · 2022: 75 · 2023: 197 · 2024: 254 · 2025: 129 · 2026: 118
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
PRESSURE GUARD SITE SELECT (A) (K973169)Span-America Medical Systems, Inc.1998-02-20
ZAK-2000 (K972022)Cardio Systems, Inc.1998-01-22
MIGHTY AIR (K974319)Wheelchairs of Kansas1998-01-22
PHYSIO/1000 (K974070)Physio Designs, Inc.1998-01-06
SIMPULSE (K972549)Kinetic Concepts, Inc.1997-11-18
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (K970081)Cathay Consolidated, Inc.1997-11-07
BARIAIR (K955243)Kinetic Concepts, Inc.1997-10-23
KT AIR BED (K970468)Kinetic Concepts, Inc.1997-09-05
RID-DECUBE II (K965207)Skin Care Management, Inc.1997-08-21
ALTERNATING PRESSURE AIR FLOTATION MATTRESS (K972153)Decubiti Concepts, Inc.1997-07-31
REST MATTRESS (K971568)Rest Mattress1997-07-18
MODIFIED PEDIKAIR (K954320)Kinetic Concepts, Inc.1997-07-18
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM (K970362)Apex Metal, Inc.1997-05-16
REST X SYSTEM (K970428)Restxsys1997-05-14
EQUI-PISE 1000 MRS (K970350)Advanced Air Support Consultancy, Inc.1997-04-22
LUMEX AIR (K963674)Lumex, Inc.1997-01-10
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM (K962585)United Medical Equipment, Inc.1997-01-07
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS (K963620)9th Wave, Inc.1997-01-07
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD (K963677)9th Wave, Inc.1996-11-26
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS (K963626)9th Wave, Inc.1996-11-26
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM (K963510)Mellen Air Mfg., Inc.1996-11-26
AIR-MEDEX I (K961769)Robert Gold Assoc.1996-10-08
PRESSUREGUARD: SELECTCARE (K960188)Span-America Medical Systems, Inc.1996-10-02
SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (K961854)Gaymar Industries, Inc.1996-08-09
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM (K962123)Lumex, Inc.1996-07-18
POWERED LOW AIR LOSS MATTRESS SYSTEM (K961159)Span-America Medical Systems, Inc.1996-06-14
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (K960620)Span-America Medical Systems, Inc.1996-04-25
AREMA II (K961129)Mellen Air Mfg., Inc.1996-04-17
ALTACARE (K955874)Asf Industries, Inc.1996-03-22
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS (K960411)Invacare Corp.1996-03-18
THE AIRCEL SYSTEM (K954593)Marcon Group, Inc.1996-02-06
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (K954766)Span-America Medical Systems, Inc.1996-01-11
CARDIO-SYSTEMS PRO-OP (K953196)Ch Administration, Inc.1995-11-08
PRESSUREGUARD IV (K953503)Span-America Medical Systems, Inc.1995-10-24
ALTADYNE (K953675)Lumex, Inc.1995-09-28
PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) (K952610)Plexus Medical1995-09-13
AMERIMED AS110 (K953069)Amerimed Systems L.C.1995-08-31
ERGOMAT 5000 SYSTEM (K952093)Ergo-Air, Inc.1995-07-26
ERGOMAT 8000 SYSTEM (K952092)Ergo-Air, Inc.1995-07-26
BAZOOKA SYSTEM (K951469)Innovative Medical Systems, Inc.1995-06-28
THE LOTECON PERSONAL CARE SYSTEM (K950191)Lotecon, Inc.1995-06-12
PRESSUREGUARD IV (K951112)Span-America Medical Systems, Inc.1995-06-06
TRIADYNE (K944094)Kinetic Concepts, Inc.1995-05-23
MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT (K945845)Micos Medical Systems1995-05-03
MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS (K945629)Micos Medical Systems1995-04-14
PEGASUS BIWAVE PLUS SYSTEM (K944310)Pegasus Airwave, Inc.1995-03-17
PARAGON PORTABLE (K945041)Pegabus Egerton, Ltd.1995-03-16
LAKE STAGEZERO(TM) AIR FLOTATION BED (K943162)Lake Medical Products, Inc.1995-02-27
DYNAMEDICS ASAR (K941083)Dynamedics Corporation1995-01-20
P/2000 (K944411)Plexus Medical1994-12-27
CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM (K943097)Global Medical Technologies, Inc.1994-12-23
PLEXUS/1000 (K943353)Plexus Medical1994-12-12
MEDAIR EXCEL 2000 (K942920)Medifloat, Inc.1994-09-19
SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS (K934817)Surgical Design Corp.1994-06-17
STRYKER 5000 (K935949)Stryker Medical1994-06-17
APEX MEDICAL AIR PUMPS (K933965)Apex Medical, Inc.1994-03-17
TURBO II (K933402)Kinetic Concepts, Inc.1994-03-15
PEGASUS BIWAVE SYSTEM (K933004)Pegasus Airwave, Inc.1994-03-07
STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM (K933091)Creative Medical, Inc.1993-12-21
PRESSUREGUARD IV (K932681)Span-America Medical Systems, Inc.1993-11-12
PREMIUM (K930673)Kinetic Concepts, Inc.1993-08-02
PRO-2000 LOW AIR LOSS THERAPY BED (K926403)Ch Administration, Inc.1993-07-30
SKYTRON LIFE ISLAND 21 (K926045)Skytron, Div. the Kmw Group, Inc.1993-07-27
LIFE ISLAND 21 (K925651)Keisei (Usa) Co., Ltd.1993-07-27
SANKEN MAT (K924005)Shima American Corp.1993-06-17
THE KAUFMANN LIFT-AND-TURN MATTRESS (K915306)Kaufmann Sjukvardsartiklar1993-01-27
BIO THERAPY PLUS (K922205)Sunrise Medical, Inc.1992-08-11
TALLEY MICRO SYSTEM/TALLEY RIPPLEBED (K914775)Talley Group, Ltd.1992-04-10
PROACT CLA-1500 SYSTEM (K915061)Clinical Systems, Inc.1992-01-31
TURNSOFT MATTRESS (K913933)Turnsoft, Inc.1992-01-10
PROFILE, A CRITICAL CARE LOW AIR LOSS BED (K901901)Kinetic Concepts, Inc.1990-10-03
LUMISCOPE ALTERNATING PRESSURE PAD & PUMP (K901096)Lumiscope Co., Inc.1990-08-21
ALTERNATING PRESSURE PUMP AND PAD SYSTEM (K900871)Three Bears Intl.1990-04-04
BIO FLOTE(R) (K900131)Bio Clinic Co.1990-02-16
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD (K891259)Diamond Medical Equipment, Inc.1989-11-17
DR. VOLKNER'S LAMELLAR TURNING BED(TM) (K891457)James Consolidated, Inc.1989-06-20
HUNTLEIGH DYNAMIC FLOTATION SYSTEM (K890012)Huntleigh Technology, Inc.1989-03-29
BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM (K883256)Bio Clinic Co.1988-10-31
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 (K882644)Huntleigh Technology, Inc.1988-08-10
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM (K882092)Gaymar Industries, Inc.1988-07-13
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM (K882161)Ssi Medical Services, Inc.1988-07-12
PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER (K874877)Pegasus Airwave, Inc.1988-02-22
ORTHODERM THERAPY BED (K874801)Health Products, Inc.1988-02-05
LOW AIR LOSS BED (K871705)Integrated Medical Equipment Co.1987-10-09
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (K872228)American Pharmaseal Div. Ahsc1987-09-04
HUNTLEIGH BETA II HM85 (K870681)Huntleigh Technology, Inc.1987-03-04
MEDSENTRY FLOTATION SYSTEM (K863152)Medsentry Corp.1986-09-23
AUTO TURNER (K850419)George J. Kamilar1985-05-21
MEDSENTRY SOFTOUCH SYSTEM (K844499)Medsentry Corp.1985-01-30
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP (K844879)Huntleigh Technology, Inc.1985-01-25
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES (K844880)Huntleigh Technology, Inc.1985-01-25
PEGASUS MATTRESS (K833964)Dermalex Co.1984-01-30
AIR MATTRESS (K813407)Trans World Agency, Inc.1981-12-31
AMERICAN AIRCARE SYSTEM (K811684)American Hamilton1981-07-02
MATTRESS, AIR FLOATATION, ALTERN. PRESS. (K803307)Intl. Medical Equipment Corp.1981-01-13
ABCO/GRANT ALTERNATING PRESSURE PAD & UT (K800231)Abco Dealers, Inc.1980-02-26
COMFICARE PAD (FOR SINGEL PT USE) (K792001)Hamilton Industries, Inc.1979-10-26
BED PADS: D-12 AND D-8 (K781404)Grant Airmass Corp.1978-09-07
AIR-FLO ALTERNATING PRESSURE PAD SYSTEM (K780906)Gaymar Industries, Inc.1978-08-10
NOVA AIR FLOATATION SYSTEM (K780502)Nova Health Systems, Inc.1978-04-10
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