Submission Details
| 510(k) Number | K241781 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Solo Pace Control
Jan 2025
Decision
204d
Days
Class 2
Risk
About This 510(k) Submission
K241781 is an FDA 510(k) clearance for the Solo Pace Control, a Pulse-generator, Pacemaker, External (Class II — Special Controls, product code DTE), submitted by Solo Pace, Inc. (Petaluma, US). The FDA issued a Cleared decision on January 10, 2025, 204 days after receiving the submission on June 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.
Device Classification
| Product Code | DTE — Pulse-generator, Pacemaker, External |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3600 |
Manufacturer
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