| K-number | K251114 |
| Device name | FloPatch FP120 |
| Applicant | Flosonics Medical |
| Product code | DPW |
| Device class | Class II |
| Decision date | Jun 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2100 |
The FloPatch FP120 is a non-invasive, wearable ultrasound-based blood flow measurement device using Doppler technology to assess peripheral blood flow. It consists of an adhesive-mounted signal processing unit that transmits ultrasonic waves, receives Doppler-shifted reflections from blood cells, and wirelessly transmits data to a mobile application for display of velocity, flow time, and other hemodynamic parameters. Intended for use by medical professionals in hospitals and clinics on adult patients only.
The subject device operates at 4 MHz center frequency in continuous wave mode only, with improved acoustic output (Max ISPTA 53.58 mW/cm² vs. predicate's 105.99 mW/cm²), updated lithium polymer battery technology (4.2V vs. predicate's same), enhanced wireless mobile application display capabilities (Doppler waveform, max velocity, VTI, corrected flow time, peak systolic velocity), and expanded contact duration to <30 days with intact skin vs. predicate's <24 hours. Dimensions, single-use design, and theory of operation remain substantially similar.
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), IEC 60601-1-12 (emergency service environment), ISO 10993-1, -5, -10, -12, -21 (biocompatibility), and IP67 (ingress protection testing).
The subject device is substantially equivalent because it maintains identical indications for use (noninvasive peripheral blood flow assessment), same intended users and environments, identical operational mode and theory of operation, and comparable or improved acoustic safety parameters relative to the predicate. The modifications—expanded contact duration, improved software display capabilities, refined hardware, and new adhesive material—do not alter the fundamental function or safety profile, as demonstrated by passing comprehensive testing for ultrasound safety, electrical performance, biocompatibility, and usability that validates the device meets or exceeds applicable standards.
View the full FDA submission: accessdata.fda.gov