FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solo Pace Control
K Number: K241781
·
Decision Jan 10, 2025
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
2
Review Days
204
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
- Solo Pace Control
- K Number
- K241781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solo Pace, Inc.
- Date Received
- June 20, 2024
- Decision Date
- January 10, 2025
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTE), ordered by most recent decision date.
Lifetech Cardio Temporary Pacemaker
FDA 510(k)
FDA Class 2
·Cardiovascular
Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Lifetech Cardio Model 8301 Temporary Pacemaker
FDA 510(k)
FDA Class 2
·Cardiovascular
Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Medtronic Model 53401 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Solo Pace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Jan 9, 2026 | Substantially Equivalent |