FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kneevoice Cartilage Evaluation System (750-3600-001)
K Number: K252076
·
Decision Feb 6, 2026
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
1
Review Days
219
Basic Information
- Device Name
- Kneevoice Cartilage Evaluation System (750-3600-001)
- K Number
- K252076
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kneevoice, Inc.
- Date Received
- July 2, 2025
- Decision Date
- February 6, 2026
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQD), ordered by most recent decision date.
AiSteth®
FDA 510(k)
FDA Class 2
·Cardiovascular
Tyto Stethoscope (G3)
FDA 510(k)
FDA Class 2
·Cardiovascular
eMurmur Heart AI
FDA 510(k)
FDA Class 2
·Cardiovascular
Stethophone Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Eko Foundation Analysis Software with Transformers (EFAST)
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurSound Electronic Stethoscope (AS101)
FDA 510(k)
FDA Class 2
·Cardiovascular