# K152991: OptoWire Deux

- Pathway: 510(k) (Traditional)
- Applicant: Opsens
- Decided: Feb 11, 2016 after 121 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: 7 generations back to K823434 (1982). 18 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142598: Opto Wire and OptoMonitor System, Opsens, Inc. (2015) Summary page 4.

## Most influential descendants
- K191907: OptoWire III (2020), 5 descendants of its own
- K213854: SavvyWire (2022), 4 descendants of its own
- K241418: OptoMonitor 3 (2025), 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
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

Source page: https://510kreport.com/device/K152991
Methodology: https://510kreport.com/methodology