Solo Pace Control— 510(k) K241781

Name: FDA 510(k) clearance K241781
Creator: U.S. Food and Drug Administration
Published: 2025-01-10

Substantially Equivalent

Solo Pace, Inc.

FDA 510(k) clearance K241781 for Solo Pace Control, Substantially Equivalent on 2025-01-10. Applicant: Solo Pace, Inc.. Device class: 2.

Clearance details

Applicant: Solo Pace, Inc.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 2024-06-20
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTE

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K232721 — Lifetech Cardio Temporary Pacemaker2024-01-07
K201011 — Medtronic Model 5392 External Pulse Generator (EPG)2020-05-13
K190825 — Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28
K181973 — Medtronic Model 5392 External Pulse Generator (EPG)2018-08-21

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K252674 — Solo Pace Fusion System (SOLOFUSE1)2026-01-09

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.