Cleared Special

K252810 - FloPatch FP120

K252810 is an FDA 510(k) clearance for FloPatch FP120, manufactured by Flosonics Medical. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Special 510(k) pathway after a 233-day FDA review.

K252810 · Flosonics Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
233d
Days
Class 2
Risk

K252810 is an FDA 510(k) clearance for the FloPatch FP120. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Flosonics Medical (Toronto, CA). The FDA issued a Cleared decision on April 24, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K252810

510(k) Number K252810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2025
Decision Date April 24, 2026
Days to Decision 233 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Modification to existing cleared device.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 138
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K252810.
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
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K243852 · Elfi-Tech , Ltd. · Apr 2025
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K241583 · Remington Medical, Inc. · Aug 2024
K252810 · FloPatch FP120
Download PDF FDA Summary Flosonics Medical