FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Respiration Rate algorithm
K Number: K251326
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
136
Review Days
408
Basic Information
- Device Name
- Respiration Rate algorithm
- K Number
- K251326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- April 29, 2025
- Decision Date
- June 11, 2026
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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