# K251367: OptoMonitor 3

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: Jan 16, 2026 after 260 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: 12 generations back to K823434 (1982). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241418: OptoMonitor 3, Opsens, Inc. (2025) Summary page 5.

## Indications for use
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

Source page: https://510kreport.com/device/K251367
Methodology: https://510kreport.com/methodology