510(k) K252810

Device
FloPatch FP120
Applicant
Flosonics Medical
510(k) number
K252810
Product code
DPW
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2025-09-03
Regulation
870.2100
Classification name
Flowmeter, Blood, Cardiovascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Caleb Chin
Address
325 Front St. W, Floor 4 Toronto CA M5V2Y1 M5V2Y1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DPW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.2025-11-20
K251114FloPatch FP120Flosonics Medical2025-06-20
K243852Elfor-LElfi-Tech , Ltd.2025-04-14
K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.2024-08-30
K223843FloPatch FP120Flosonics Medical2023-05-03
K222242FloPatch FP120Flosonics Medical2022-12-09
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc.2022-04-20
K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc.2022-01-27
K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc.2021-10-07
K201114Bidop 7Koven Technology, Inc.2021-01-05
K200337FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.)2020-03-24
K192966FlowMetLaser Associated Sciences, Inc.2020-01-10
K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare , Ltd.2019-09-06
K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.)2019-06-21
K182494FlowMet-RLaser Associated Sciences, Inc.2019-02-27