Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FNM — Predicate Candidate Screening
102 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
255 days90th percentile
102clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | 1998-02-20 | 179 | 0 |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | 1998-01-22 | 234 | 0 |
| K974319 | MIGHTY AIR | Wheelchairs of Kansas | 1998-01-22 | 66 | 0 |
| K974070 | PHYSIO/1000 | Physio Designs, Inc. | 1998-01-06 | 70 | 0 |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | 1997-11-18 | 133 | 0 |
| K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | Cathay Consolidated, Inc. | 1997-11-07 | 302 | 0 |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | 1997-10-23 | 708 | 1 |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | 1997-09-05 | 210 | 1 |
| K965207 | RID-DECUBE II | Skin Care Management, Inc. | 1997-08-21 | 237 | 0 |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | 1997-07-31 | 52 | 0 |
| K971568 | REST MATTRESS | Rest Mattress | 1997-07-18 | 80 | 0 |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | 1997-07-18 | 680 | 0 |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | 1997-05-16 | 105 | 0 |
| K970428 | REST X SYSTEM | Restxsys | 1997-05-14 | 99 | 0 |
| K970350 | EQUI-PISE 1000 MRS | Advanced Air Support Consultancy, Inc. | 1997-04-22 | 82 | 0 |
| K963674 | LUMEX AIR | Lumex, Inc. | 1997-01-10 | 119 | 0 |
| K962585 | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | United Medical Equipment, Inc. | 1997-01-07 | 190 | 0 |
| K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 9th Wave, Inc. | 1997-01-07 | 119 | 0 |
| K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 9th Wave, Inc. | 1996-11-26 | 74 | 0 |
| K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 9th Wave, Inc. | 1996-11-26 | 76 | 0 |
| K963510 | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTE | Mellen Air Mfg., Inc. | 1996-11-26 | 84 | 0 |
| K961769 | AIR-MEDEX I | Robert Gold Assoc. | 1996-10-08 | 153 | 0 |
| K960188 | PRESSUREGUARD: SELECTCARE | Span-America Medical Systems, Inc. | 1996-10-02 | 260 | 0 |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Gaymar Industries, Inc. | 1996-08-09 | 87 | 0 |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | Lumex, Inc. | 1996-07-18 | 48 | 0 |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-06-14 | 84 | 0 |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-04-25 | 72 | 0 |
| K961129 | AREMA II | Mellen Air Mfg., Inc. | 1996-04-17 | 27 | 0 |
| K955874 | ALTACARE | Asf Industries, Inc. | 1996-03-22 | 85 | 0 |
| K960411 | MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOT | Invacare Corp. | 1996-03-18 | 49 | 0 |
| K954593 | THE AIRCEL SYSTEM | Marcon Group, Inc. | 1996-02-06 | 126 | 0 |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | Span-America Medical Systems, Inc. | 1996-01-11 | 86 | 0 |
| K953196 | CARDIO-SYSTEMS PRO-OP | Ch Administration, Inc. | 1995-11-08 | 125 | 0 |
| K953503 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-10-24 | 90 | 0 |
| K953675 | ALTADYNE | Lumex, Inc. | 1995-09-28 | 52 | 0 |
| K952610 | PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) | Plexus Medical | 1995-09-13 | 98 | 0 |
| K953069 | AMERIMED AS110 | Amerimed Systems L.C. | 1995-08-31 | 62 | 0 |
| K952093 | ERGOMAT 5000 SYSTEM | Ergo-Air, Inc. | 1995-07-26 | 84 | 0 |
| K952092 | ERGOMAT 8000 SYSTEM | Ergo-Air, Inc. | 1995-07-26 | 84 | 0 |
| K951469 | BAZOOKA SYSTEM | Innovative Medical Systems, Inc. | 1995-06-28 | 90 | 0 |
| K950191 | THE LOTECON PERSONAL CARE SYSTEM | Lotecon, Inc. | 1995-06-12 | 146 | 0 |
| K951112 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-06-06 | 88 | 0 |
| K944094 | TRIADYNE | Kinetic Concepts, Inc. | 1995-05-23 | 274 | 0 |
| K945845 | MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT | Micos Medical Systems | 1995-05-03 | 154 | 0 |
| K945629 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS | Micos Medical Systems | 1995-04-14 | 149 | 0 |
| K944310 | PEGASUS BIWAVE PLUS SYSTEM | Pegasus Airwave, Inc. | 1995-03-17 | 196 | 0 |
| K945041 | PARAGON PORTABLE | Pegabus Egerton, Ltd. | 1995-03-16 | 153 | 0 |
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | Lake Medical Products, Inc. | 1995-02-27 | 241 | 0 |
| K941083 | DYNAMEDICS ASAR | Dynamedics Corporation | 1995-01-20 | 318 | 0 |
| K944411 | P/2000 | Plexus Medical | 1994-12-27 | 110 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda