BPAP System
FDA 510(k) K213169 · BMC Medical Co., Ltd.
510(k) numberK213169
Submission
- Device name
- BPAP System
- Applicant
- BMC Medical Co., Ltd.
Beijing, CN - Received
- September 28, 2021
- Decision date
- December 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNS – Ventilator, Continuous, Non-Life-Supporting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
Other 510(k)s with product code MNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251889 | myAirMNS · Traditional | Resmed Corp | 04/08/2026SE |
| K252078 | BreathePal Bilevel (GFM50-MD2201)MNS · Traditional | Compal Electronics, Inc. | 03/17/2026SE |
| K251661 | Mariana Minerva; Mariana NimbusMNS · Traditional | Resmed Pty , Ltd. | 02/23/2026SE |
| K240778 | Vivo 1, Vivo 2MNS · Traditional | Breas Medical AB | 12/13/2024SE |
| K231064 | ReddyPort ElbowMNS · Traditional | Smd Manufacturing, LLC | 07/13/2023SE |
| K171827 | ReddyPort NIV Access ElbowMNS · Traditional | Smd Manufacturing, LLC | 01/19/2018SE |
| K161492 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 01/19/2017SE |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP TxMNS · Traditional | Resmed, Ltd. | 09/09/2016SE |
| K153061 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 04/13/2016SE |
| K132371 | Easycare OnlineMNS · Traditional | Resmed, Ltd. | 11/22/2013SE |
More from Resmed, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | 08/14/2026SE |
| 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 |
| 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 BPAP System cleared by the FDA?
BPAP System (K213169) received a 510(k) decision of Substantially Equivalent on December 5, 2022, 433 days after the submission was received.
What is the product code of K213169?
The FDA product code is MNS – Ventilator, Continuous, Non-Life-Supporting, a Class II (moderate risk) device regulated under 21 CFR 868.5895.