# K161263: OptoMonitor II

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: Sep 13, 2016 after 131 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.
No later device cites it as a predicate yet.
0 of 19 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.

## Indications for use
The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.

Source page: https://510kreport.com/device/K161263
Methodology: https://510kreport.com/methodology