LIFESTYLE OXYGEN CONCENTRATOR— 510(k) K020324
Substantially EquivalentAirsep Corp.
FDA 510(k) clearance K020324 for LIFESTYLE OXYGEN CONCENTRATOR, Substantially Equivalent on 2002-03-13. Applicant: Airsep Corp.. Device class: 2.
Clearance details
- Applicant
- Airsep Corp.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Recent devices under product code CAW
view allMore clearances from Airsep Corp.
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K020324
K-number listed on FDA's recall record- Z-0478-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
- Z-0479-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Z-0768-2013 — Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020324.
Data sourced from openFDA. This site is unofficial and independent of the FDA.