Data / Medical devices / United States / Solo Pace Inc
Solo Pace Inc: FDA-registered device maker in Brooklyn Park, MN, United States, 2 510(k) clearances
Solo Pace Inc is registered with the FDA (registration 3035372913) in Brooklyn Park, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035372913
- Address
- 7125 Northland Ter N, Brooklyn Park, MN, United States, 55428
- Owner or operator
- Solo Pace Inc (10092533)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 17, 2025
- Registered through
- 2026
- Brand names listed
- Solo Pace Control, SoloPace Fusion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Pacemaker, Temporary | LDF | 2 | Specification developer | accessdata.fda.gov |
| Pulse-Generator, Pacemaker, External | DTE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2026 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | DQX | Substantially Equivalent | Solo Pace, Inc. | accessdata.fda.gov |
| January 10, 2025 | K241781 | Solo Pace Control | DTE | Substantially Equivalent | Solo Pace, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Electrode, Pacemaker, Temporary
- All makers of Pulse-Generator, Pacemaker, External
Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.