Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airsep Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
420 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101154 | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND | Airsep Corp. | 2011-03-28 | 339 | 0 |
| K080348 | OXISCAN II DATA MANAGEMENT SYSTEM | Airsep Corp. | 2008-10-09 | 241 | 0 |
| K020324 | LIFESTYLE OXYGEN CONCENTRATOR | Airsep Corp. | 2002-03-13 | 41 | 3 |
| K012037 | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 | Airsep Corp. | 2002-01-17 | 202 | 0 |
| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | Airsep Corp. | 2000-10-20 | 210 | 0 |
| K001579 | IMPULSE SELECT | Airsep Corp. | 2000-08-31 | 101 | 0 |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Airsep Corp. | 2000-08-01 | 83 | 0 |
| K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Airsep Corp. | 2000-05-16 | 48 | 0 |
| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Airsep Corp. | 1999-08-27 | 51 | 0 |
| K983002 | MYSTIQUE ULTRASONIC NEBULIZER | Airsep Corp. | 1998-10-16 | 49 | 0 |
| K960309 | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) | Airsep Corp. | 1997-02-28 | 420 | 0 |
| K962865 | REMBRANDT SYSTEM | Airsep Corp. | 1996-10-25 | 94 | 0 |
| K962766 | AIRSEP IMPULSE | Airsep Corp. | 1996-10-10 | 86 | 0 |
| K943207 | NITELIFE BI-LEVEL CPAP | Airsep Corp. | 1996-07-29 | 755 | 0 |
| K951882 | ECO CHECK (ECOVALVE AND OXYGEN MONITOR) | Airsep Corp. | 1995-10-16 | 196 | 0 |
| K944020 | AIRSEP NEWLIFE AIR OUTLET OPTION | Airsep Corp. | 1995-03-16 | 212 | 0 |
| K884581 | RELIANT OXYGEN CONCENTRATOR | Airsep Corp. | 1989-01-11 | 70 | 0 |
| K872534 | 4LYF OXYGEN CONCENTRATOR | Airsep Corp. | 1987-10-13 | 109 | 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