FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
BPAP System
K Number: K213169
·
Decision Dec 5, 2022
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
46
Applicant Total
5
Review Days
433
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BPAP System
- K Number
- K213169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BMC Medical Co., Ltd.
- Date Received
- September 28, 2021
- Decision Date
- December 5, 2022
- Product Code
- MNS
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNS | Ventilator, Continuous, Non-Life-Supporting | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNS), ordered by most recent decision date.
myAir
FDA 510(k)
FDA Class 2
·Anesthesiology
BreathePal Bilevel (GFM50-MD2201)
FDA 510(k)
FDA Class 2
·Anesthesiology
Mariana Minerva; Mariana Nimbus
FDA 510(k)
FDA Class 2
·Anesthesiology
Vivo 1, Vivo 2
FDA 510(k)
FDA Class 2
·Anesthesiology
ReddyPort Elbow
FDA 510(k)
FDA Class 2
·Anesthesiology
ReddyPort NIV Access Elbow
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by BMC Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | Apr 29, 2026 | Substantially Equivalent |
| K242935 | Respiration Data Management Software (PAP Link PC) | Jan 15, 2025 | Substantially Equivalent |
| K211155 | Auto CPAP System | Mar 9, 2022 | Substantially Equivalent |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | Apr 23, 2014 | Substantially Equivalent |