| K-number | K251367 |
| Device name | OptoMonitor 3 |
| Applicant | Opsens, Inc. |
| Product code | DXO |
| Device class | Class II |
| Decision date | Jan 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.2870 |
The OptoMonitor 3 is a catheter-tip pressure transducer system that measures cardiovascular blood pressure in heart chambers, coronary vessels, and peripheral vessels during interventional procedures. It provides hemodynamic information such as fractional flow reserve (FFR) for diagnosis and treatment of blood vessels, and valve gradients during structural heart procedures.
The subject device adds a new Capture Unit (optional hardware) for angiography video acquisition and a PhysioVU software feature that displays time-synchronized playback of angiogram and physiological pullback values (Pd/Pa, dPR). A dPR Pullback optimization (Pullback 2) was incorporated for synchronization. The core pressure sensing technology (fiberoptic sensor embedded in guidewire), signal processing, operating parameters, and performance specifications (accuracy ±1 mmHg plus ±1–3% of reading, pressure range −30 to 300 mmHg) remain identical to the predicate.
IEC 62304:2006/AMD1:2015 (Medical device software – Software life cycle processes); IEC 60601-1:2020 Edition 3.2 and IEC 60601-1-2:2020 Edition 4.1 (Electrical safety and electromagnetic compatibility).
The OptoMonitor 3 is substantially equivalent to the predicate (K241418) because it retains the same indications for use, identical core pressure measurement technology and performance specifications, and the same regulatory classification (Class II, product code DXO). The new video capture and PhysioVU display features do not impact safety or effectiveness—verification and validation testing confirmed proper operation, synchronization performance, and compliance with electrical safety standards, with no new safety questions identified.
View the full FDA submission: accessdata.fda.gov