# K192340: OptoMonitor

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: Dec 12, 2019 after 106 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- 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.
7 later devices descend from it; 2 cite it directly.
0 of 26 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.
- K111395: Primewire Prestige Plus, Volcano Corporation (2011) Summary page 7.
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 7.

## Most influential descendants
- K193620: OptoMonitor 3 (2020), 6 descendants of its own
- K202943: OptoMonitor 3 (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

## Indications for use
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or 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/K192340
Methodology: https://510kreport.com/methodology