Airlife, Inc.: FDA filings under this applicant name
FDA lists 76 510(k) clearances under the applicant name “Airlife, Inc.” (first 1979, latest 1984), across 20 product codes in 2 review panels. Median 510(k) review time under this name: 25 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 16 | 16 |
| BZA | Connector, Airway (Extension) | 11 | 11 |
| BYX | Tubing, Pressure And Accessories | 7 | 7 |
| BYG | Mask, Oxygen | 6 | 6 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 5 | 5 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 5 | 5 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| BYH | Drain, Tee (Water Trap) | 2 | 2 |
Plus 10 more product codes.
Review panels
- Anesthesiology (71)
- General Hospital (2)
Most recent Airlife, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834573 | AQUA TRAP | BYH | 1984-03-05 | 67 |
| K834570 | VOLUME VENTILATOR CIRCUIT W/WATER TRAP | BZO | 1984-03-05 | 67 |
| K834077 | SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN | CAF | 1983-12-12 | 17 |
| K833196 | VOLUME VENTILATOR CIRCUIT-NEBULIZER | CAI | 1983-11-03 | 45 |
| K833197 | TRACH SWIVE/CONNECTOR | BTR | 1983-10-28 | 39 |
| K832725 | DUAL DIAL VENTURI STYLE MASK | BYF | 1983-09-20 | 39 |
| K831246 | WHISTLER IN-LINE PRESSURE RELEASE VALVE | CBP | 1983-07-26 | 99 |
| K830895 | SINGLE USE NEBULIZER, ADJUST. AIR- | CAF | 1983-04-28 | 38 |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | KFZ | 1983-04-18 | 28 |
| K821129 | AIRLIFE NEBULIZER HEATER | CAF | 1982-05-18 | 28 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Airlife, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Airlife, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Airlife, Inc.?
FDA lists 76 510(k) clearances under the applicant name “Airlife, Inc.” (first 1979, latest 1984), across 20 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Airlife, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Airlife, Inc. is 25 days.
Which FDA product codes appear under Airlife, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 16); BZA (Connector, Airway (Extension), 11); BYX (Tubing, Pressure And Accessories, 7).
Next steps
- See all 76 Airlife, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Airlife, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.