# K142598: Opto Wire and OptoMonitor System

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: Jun 12, 2015 after 270 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: 6 generations back to K823434 (1982). 17 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111395: Primewire Prestige Plus, Volcano Corporation (2011) Summary page 4.
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 4.

## Most influential descendants
- K192340: OptoMonitor (2019), 7 descendants of its own
- K193620: OptoMonitor 3 (2020), 6 descendants of its own
- K152991: OptoWire Deux (2016), 6 descendants of its own
- K202943: OptoMonitor 3 (2020), 5 descendants of its own
- K191907: OptoWire III (2020), 5 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/K142598
Methodology: https://510kreport.com/methodology