# K241781: Solo Pace Control

- Pathway: 510(k) (Traditional)
- Applicant: Solo Pace, Inc.
- Decided: Jan 10, 2025 after 204 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Model 5392 External Pulse Generator (EPG): named in the summary without a submission number

## Indications for use
The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to: • Complete heart block • Sinus bradycardia • Sick sinus syndrome • Bradycardia with congestive heart failure • Cardiac complications during invasive or surgical procedures • Support, management, and evaluation of a patient before permanent pacemaker implantation • Support during permanent pacemaker replacement • Interventional cardiology procedures where pacing is required

Source page: https://510kreport.com/device/K241781
Methodology: https://510kreport.com/methodology