Product code FNM— General Hospital
PRESSUREGUARD IV
- Classification name
- Mattress, Air Flotation, Alternating Pressure
- Device class
- Class 2
- Regulation
- 21 CFR 880.5550
- Advisory panel
- General Hospital
- Total cleared
- 102
- First cleared
- Most recent
Market context for product code FNM
FDA has cleared devices under product code FNM between 1976 and 1998, filed by 68 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1981
Top applicants under product code FNM
Adverse events under product code FNM
product code FNM- Death
- 22
- Injury
- 349
- Other
- 4
- Total
- 375
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FNM
1–100 of 102- K973169 — PRESSURE GUARD SITE SELECT (A)
- K972022 — ZAK-2000
- K974319 — MIGHTY AIR
- K974070 — PHYSIO/1000
- K972549 — SIMPULSE
- K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
- K955243 — BARIAIR
- K970468 — KT AIR BED
- K965207 — RID-DECUBE II
- K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS
- K954320 — MODIFIED PEDIKAIR
- K971568 — REST MATTRESS
- K970362 — CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
- K970428 — REST X SYSTEM
- K970350 — EQUI-PISE 1000 MRS
- K963674 — LUMEX AIR
- K962585 — UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
- K963620 — 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
- K963510 — APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
- K963626 — 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
- K963677 — 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
- K961769 — AIR-MEDEX I
- K960188 — PRESSUREGUARD: SELECTCARE
- K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212
- K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
- K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM
- K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
- K961129 — AREMA II
- K955874 — ALTACARE
- K960411 — MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
- K954593 — THE AIRCEL SYSTEM
- K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
- K953196 — CARDIO-SYSTEMS PRO-OP
- K953503 — PRESSUREGUARD IV
- K953675 — ALTADYNE
- K952610 — PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)
- K953069 — AMERIMED AS110
- K952092 — ERGOMAT 8000 SYSTEM
- K952093 — ERGOMAT 5000 SYSTEM
- K951469 — BAZOOKA SYSTEM
- K950191 — THE LOTECON PERSONAL CARE SYSTEM
- K951112 — PRESSUREGUARD IV
- K944094 — TRIADYNE
- K945845 — MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT
- K945629 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
- K944310 — PEGASUS BIWAVE PLUS SYSTEM
- K945041 — PARAGON PORTABLE
- K943162 — LAKE STAGEZERO(TM) AIR FLOTATION BED
- K941083 — DYNAMEDICS ASAR
- K944411 — P/2000
- K943097 — CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
- K943353 — PLEXUS/1000
- K942920 — MEDAIR EXCEL 2000
- K934817 — SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS
- K935949 — STRYKER 5000
- K933965 — APEX MEDICAL AIR PUMPS
- K933402 — TURBO II
- K933004 — PEGASUS BIWAVE SYSTEM
- K933091 — STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM
- K932681 — PRESSUREGUARD IV
- K930673 — PREMIUM
- K926403 — PRO-2000 LOW AIR LOSS THERAPY BED
- K925651 — LIFE ISLAND 21
- K926045 — SKYTRON LIFE ISLAND 21
- K924005 — SANKEN MAT
- K915306 — THE KAUFMANN LIFT-AND-TURN MATTRESS
- K922205 — BIO THERAPY PLUS
- K914775 — TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
- K915061 — PROACT CLA-1500 SYSTEM
- K913933 — TURNSOFT MATTRESS
- K901901 — PROFILE, A CRITICAL CARE LOW AIR LOSS BED
- K901096 — LUMISCOPE ALTERNATING PRESSURE PAD & PUMP
- K900871 — ALTERNATING PRESSURE PUMP AND PAD SYSTEM
- K900131 — BIO FLOTE(R)
- K891259 — MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
- K891457 — DR. VOLKNER'S LAMELLAR TURNING BED(TM)
- K890012 — HUNTLEIGH DYNAMIC FLOTATION SYSTEM
- K883256 — BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
- K882644 — HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
- K882092 — CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
- K882161 — ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
- K874877 — PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
- K874801 — ORTHODERM THERAPY BED
- K871705 — LOW AIR LOSS BED
- K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
- K870681 — HUNTLEIGH BETA II HM85
- K863152 — MEDSENTRY FLOTATION SYSTEM
- K850419 — AUTO TURNER
- K844499 — MEDSENTRY SOFTOUCH SYSTEM
- K844879 — HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
- K844880 — HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
- K833964 — PEGASUS MATTRESS
- K813407 — AIR MATTRESS
- K811684 — AMERICAN AIRCARE SYSTEM
- K803307 — MATTRESS, AIR FLOATATION, ALTERN. PRESS.
- K800231 — ABCO/GRANT ALTERNATING PRESSURE PAD & UT
- K792001 — COMFICARE PAD (FOR SINGEL PT USE)
- K781404 — BED PADS: D-12 AND D-8
- K780906 — AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
- K780502 — NOVA AIR FLOATATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.