# K151244: Pre-Formed Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Jun 11, 2015 after 31 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: 2 generations back to K930622 (1993). 2 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130798: Pre-Formed Guidewires, Lake Region Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K213854: SavvyWire (2022), 4 descendants of its own
- K241418: OptoMonitor 3 (2025), 1 descendant of its own
- K153397: S-Wire Guidewire System (2016), 1 descendant of its own
- K251367: OptoMonitor 3 (2026), 0 descendants of its own
- K252674: Solo Pace Fusion System (SOLOFUSE1) (2026), 0 descendants of its own

## Indications for use
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.

Source page: https://510kreport.com/device/K151244
Methodology: https://510kreport.com/methodology