# K252674: Solo Pace Fusion System (SOLOFUSE1)

- Pathway: 510(k) (Traditional)
- Applicant: Solo Pace, Inc.
- Decided: Jan 9, 2026 after 137 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K823434 (1982). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213854: SavvyWire, Opsens, Inc. (2022) Summary page 5.

## Indications for use
Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.

Source page: https://510kreport.com/device/K252674
Methodology: https://510kreport.com/methodology