Airsep Corp.: FDA clearances and approvals
Airsep Corp. has 19 FDA 510(k) clearances (first 1987, latest 2015), across 9 product codes in 2 review panels. Median 510(k) review time: 109 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 256 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 8 | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| NFB | Conserver, Oxygen | 2 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
Review panels
- Anesthesiology (15)
- Neurology (4)
Most recent Airsep Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | CAW | 2015-12-18 | 256 |
| K101154 | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L | CAW | 2011-03-28 | 339 |
| K080348 | OXISCAN II DATA MANAGEMENT SYSTEM | DQA | 2008-10-09 | 241 |
| K020324 | LIFESTYLE OXYGEN CONCENTRATOR | CAW | 2002-03-13 | 41 |
| K012037 | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 | CAW | 2002-01-17 | 202 |
| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | GWF | 2000-10-20 | 210 |
| K001579 | IMPULSE SELECT | NFB | 2000-08-31 | 101 |
| K001467 | DA VINCHI EMG/EP ISA1004EP | GWE | 2000-08-01 | 83 |
| K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | OLV | 2000-05-16 | 48 |
| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | OLV | 1999-08-27 | 51 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Airsep Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Airsep Corp.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Airsep Corp. have?
Airsep Corp. has 19 FDA 510(k) clearances (first 1987, latest 2015), across 9 product codes in 2 review panels.
How long does FDA take to clear Airsep Corp.'s 510(k)s?
The median time from FDA receipt to decision across Airsep Corp.'s cleared 510(k)s is 109 days.
What devices does Airsep Corp. make?
Its most frequent FDA product codes are CAW (Generator, Oxygen, Portable, 8); CAF (Nebulizer (Direct Patient Interface), 2); NFB (Conserver, Oxygen, 2).
Has Airsep Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Airsep Corp. Related entities may recall under other names.
Next steps
- See all 19 Airsep Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Airsep Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.