Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTI · Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
324 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | 2013-10-24 | 121 | 0 |
| K113338 | MEDICAL AIR COMPRESSOR | Oricare, Inc. | 2012-08-10 | 270 | 0 |
| K091871 | DK50 DS | Ekom S.R.O. | 2009-10-23 | 122 | 0 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | 2008-11-19 | 428 | 0 |
| K060781 | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | 2006-10-03 | 195 | 0 |
| K051691 | MINIMATE COMPRESSOR | Precision Medical, Inc. | 2005-12-09 | 169 | 0 |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | 2005-03-14 | 256 | 0 |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | 2004-12-15 | 203 | 0 |
| K041974 | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZ | Med2000 S.R.L. | 2004-08-24 | 33 | 0 |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | 2004-06-09 | 128 | 0 |
| K031686 | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | 2004-01-21 | 233 | 0 |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | 2003-10-07 | 155 | 1 |
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | 2003-09-05 | 333 | 1 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | 2002-05-03 | 52 | 0 |
| K013027 | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | 2001-12-06 | 87 | 0 |
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | 2001-03-13 | 181 | 0 |
| K002468 | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, | San UP S.A. | 2001-03-02 | 203 | 0 |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Drager, Inc. | 1998-10-29 | 80 | 1 |
| K963349 | DEVILBISS 8650D | Devilbiss Health Care, Inc. | 1997-06-13 | 291 | 0 |
| K951926 | ALRECO 40400 | Allan Rehnstrom AB | 1995-12-08 | 227 | 0 |
| K945478 | AM-50 AEROSOL/MEDICATION AIR COMPRESSOR | Preferred Medical Supply, Inc. | 1995-09-28 | 324 | 0 |
| K952616 | MICROTIME | Westmed Intl. | 1995-09-27 | 113 | 0 |
| K946039 | MODEL #5000 PULMO PLUS | International Medical Systems | 1995-06-16 | 186 | 0 |
| K940630 | 503 MAXI COMPRESSOR | Medical Industries America, Inc. | 1995-02-21 | 372 | 0 |
| K930509 | PM PUMP COMPRESSOR | Precision Medical, Inc. | 1994-10-28 | 634 | 0 |
| K925010 | NEBULIZER PUMP, POWERED, MODEL 1110 | Thomas Industries | 1994-05-27 | 602 | 0 |
| K925011 | NEBULIZER PUMP, POWERED MODEL 1180 | Thomas Industries | 1994-01-12 | 467 | 0 |
| K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | Devilbiss Health Care, Inc. | 1993-09-30 | 216 | 0 |
| K913097 | SAM ST | Ferguson Medical | 1992-12-11 | 518 | 0 |
| K922623 | NEBULIZER SYSTEM | Healthdyne, Inc. | 1992-12-01 | 182 | 0 |
| K920954 | AIR STAR | Infrasonics Corp. | 1992-08-03 | 159 | 0 |
| K902520 | AIR PLUS NEBULIZER | Diamond Medical Equipment, Inc. | 1991-03-04 | 270 | 0 |
| K904045 | #504 MINI COMPRESSOR | Medical Industries America, Inc. | 1991-02-12 | 161 | 0 |
| K902184 | MAXI ASPIRATOR | Medical Industries America, Inc. | 1991-02-12 | 274 | 0 |
| K902762 | PM14 SOFT AIR COMPRESSOR | Precision Medical, Inc. | 1990-07-30 | 35 | 0 |
| K900686 | MAXI COMPRESSORS | Medical Industries America, Inc. | 1990-04-26 | 72 | 0 |
| K894831 | PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 | Equi-Tron Mfg., Inc. | 1989-10-24 | 85 | 0 |
| K883829 | TURBO AIR COMPRESSOR 8000 | Necon Medical, Inc. | 1989-03-23 | 195 | 0 |
| K884722 | LUMINEB I | Lumiscope Co., Inc. | 1989-02-03 | 85 | 0 |
| K883704 | MULTIICHALLENGE NEBULIZER SYSTEM | Biotrine Corp. | 1988-11-28 | 90 | 0 |
| K883132 | NEBULIZER PUMP POWERED MODELS 020 AND 050 | Travelneb, Inc. | 1988-10-18 | 84 | 0 |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Mountain Medical Equipment, Inc. | 1987-10-20 | 36 | 0 |
| K871829 | SIEMENS DRY AIR COMPRESSOR | Siemens Elema AB | 1987-06-15 | 35 | 0 |
| K870428 | AEROSOL ONE, NEBULIZER PUMP | Ashai Co. , Ltd. | 1987-05-15 | 101 | 0 |
| K864547 | BIRD 6500 AIR COMPRESSOR | Bird Products Corp. | 1987-01-12 | 54 | 0 |
| K864680 | MOBIL 02 | Roman Laboratories, Inc. | 1987-01-09 | 38 | 0 |
| K863339 | DURA NEB(TM) 2000 PORTABLE COMPRESSOR | Thera Tec, Inc. | 1986-10-07 | 40 | 0 |
| K862628 | BUNN MODEL 510 MEDICATION COMPRESSOR | The John Bunn Co. | 1986-08-07 | 28 | 0 |
| K861865 | ERIE-NEB | Erie Medical | 1986-07-01 | 47 | 0 |
| K852622 | AEROSOL ONE | Ashai Co. , Ltd. | 1986-04-24 | 308 | 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