Portable Oxygen Concentrator (PO1 5B, PO1 6B)
FDA 510(k) K260171 · BMC Medical Co., Ltd.
510(k) numberK260171
Submission
- Device name
- Portable Oxygen Concentrator (PO1 5B, PO1 6B)
- Applicant
- BMC Medical Co., Ltd.
Beijing, CN - Received
- January 21, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
| K251607 | Oxygen Concentrator (J5A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 11/21/2025SE |
More from Foshan Kycare Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | 04/29/2026SE |
| K242935 | Respiration Data Management Software (PAP Link PC)BZD · Traditional | 01/15/2025SE |
| K213169 | BPAP SystemMNS · Traditional | 12/05/2022SE |
| K211155 | Auto CPAP SystemBZD · Traditional | 03/09/2022SE |
| K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)BZD · Traditional | 09/05/2017SE |
| K133009 | Nasal Mask, Nasal Mask, Full Face MaskBZD · Traditional | 04/23/2014SE |
Questions and answers
When was Portable Oxygen Concentrator (PO1 5B, PO1 6B) cleared by the FDA?
Portable Oxygen Concentrator (PO1 5B, PO1 6B) (K260171) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 205 days after the submission was received.
What is the product code of K260171?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.