Oxygen Concentrator (OX-5A, OX-5C)— 510(k) K252965
Substantially EquivalentOxytek Medical Technology Co., Ltd.
FDA 510(k) clearance K252965 for Oxygen Concentrator (OX-5A, OX-5C), Substantially Equivalent on 2026-05-29. Applicant: Oxytek Medical Technology Co., Ltd.. Device class: 2.
Summary
Oxytek Medical Technology's Oxygen Concentrator (OX-5A, OX-5C) is filed under CAW, portable oxygen generators. Apart from the two model numbers, the device name is generic.
Class II, 21 CFR 868.5440. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Oxytek filed from Chencun Town, Shunde District, Foshan, China. Review took 254 calendar days (September 17, 2025 to May 29, 2026).
Clearance details
- Applicant
- Oxytek Medical Technology Co., Ltd.
- Product code
- Product 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
- Chencun Town, Shunde District, Foshan, CN
Recent devices under product code CAW
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.