510(k) K252810

FloPatch FP120 by Flosonics Medical — Product Code DPW

K252810 is an FDA 510(k) premarket notification submitted by Flosonics Medical for the device "FloPatch FP120". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Flosonics Medical has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
September 3, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type