FloPatch FP120— 510(k) K252810
Substantially EquivalentFlosonics Medical
FDA 510(k) clearance K252810 for FloPatch FP120, Substantially Equivalent on 2026-04-24. Applicant: Flosonics Medical. Device class: 2.
Summary
Flosonics Medical's FloPatch FP120 is filed under product code DPW (Flowmeter, Blood, Cardiovascular). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 870.2100. It came in as a Special 510(k), and Cardiovascular is both the classification panel and the review panel.
Flosonics Medical filed from Toronto, Canada. Review took 233 calendar days (September 3, 2025 to April 24, 2026).
Clearance details
- Applicant
- Flosonics Medical
- Product code
- Product code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Toronto, CA
Recent devices under product code DPW
view all- K261714 — FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
- K260700 — BlueDop Vascular Expert
- K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more
- K251114 — FloPatch FP120
- K243852 — Elfor-L
More clearances from Flosonics Medical
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