Cleared Traditional

FloPatch FP120

K251114 · Flosonics Medical · Cardiovascular
Jun 2025
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K251114 is an FDA 510(k) clearance for the FloPatch FP120, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Flosonics Medical (Toronto, CA). The FDA issued a Cleared decision on June 20, 2025, 70 days after receiving the submission on April 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K251114 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date June 20, 2025
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPW — Flowmeter, Blood, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2100

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