| K-number | K252810 |
| Device name | FloPatch FP120 |
| Applicant | Flosonics Medical |
| Product code | DPW |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.2100 |
The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound device that measures blood flow velocity in peripheral vessels, including the carotid artery. It aids medical professionals in critical care settings for volume management assessment and is intended for prescription use by physicians and nurses in hospitals on adult patients only.
The device uses continuous-wave Doppler ultrasound at 4 MHz to assess arterial blood flow, displaying maximum velocity, velocity-time integral (VTI), and corrected flow time metrics. It is single-use, body-worn with adhesive backing, powered by a 4.2V lithium polymer battery, operates wirelessly with a mobile application interface, and measures validated flow velocities from 10–170 cm/s with maximum output of 53.58 mW/cm² ISPTA.3 and MI of 3.09E-02.
IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-37:2015 (ultrasound safety and performance), and ISO 10993-1, -5, -10, -12, -21 (biocompatibility).
The FloPatch FP120 is substantially equivalent to its predicate (K251114, also FloPatch FP120) because it is identical in all material respects: same classification, intended use expanded to include critical care ultrasonography for volume management with carotid assessment, same physical dimensions, power source, safety standards, and performance characteristics. The indications-for-use modification does not present changes to safety or effectiveness.
View the full FDA submission: accessdata.fda.gov