Portable Oxygen Concentrator (PO1 5B, PO1 6B)— 510(k) K260171
Substantially EquivalentBMC Medical Co., Ltd.
FDA 510(k) clearance K260171 for Portable Oxygen Concentrator (PO1 5B, PO1 6B), Substantially Equivalent on 2026-08-14. Applicant: BMC Medical Co., Ltd.. Device class: 2.
Summary
BMC Medical's Portable Oxygen Concentrator comes in two listed models, PO1 5B and PO1 6B. It's filed under product code CAW, portable oxygen generators.
Class II, 21 CFR 868.5440. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
BMC filed from Beijing, China. FDA found it substantially equivalent 205 calendar days after receipt (January 21 to August 14, 2026).
Clearance details
- Applicant
- BMC Medical 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
- Beijing, CN
Recent devices under product code CAW
view allMore clearances from BMC Medical Co., Ltd.
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.