FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OxyMinder Pro (10310)
K Number: K251245
·
Decision Aug 11, 2025
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
1
Review Days
111
Basic Information
- Device Name
- OxyMinder Pro (10310)
- K Number
- K251245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Med Device, Inc.
- Date Received
- April 22, 2025
- Decision Date
- August 11, 2025
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCL), ordered by most recent decision date.
Smart Check O2 (MA0236)
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxtec MaxO2 ME+p
FDA 510(k)
FDA Class 2
·Anesthesiology
Percent Oxygen Sensors
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyMinder
FDA 510(k)
FDA Class 2
·Anesthesiology
Accu O2 Oxygen Analyzer
FDA 510(k)
FDA Class 2
·Anesthesiology
MaxO2ME
FDA 510(k)
FDA Class 2
·Anesthesiology