FloPatch FP120

FDA 510(k) K223843 · Flosonics Medical

Substantially Equivalent

510(k) numberK223843

Submission

Device name
FloPatch FP120
Applicant
Flosonics Medical
Toronto, CA
Received
December 22, 2022
Decision date
May 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

Other 510(k)s with product code DPW

510(k)DeviceApplicantDecision
K260700BlueDop Vascular ExpertDPW · Traditional BlueDop Medical, Ltd.07/08/2026SE
K252810FloPatch FP120DPW · Special Flosonics Medical04/24/2026SE
K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional Remington Medical, Inc.11/20/2025SE
K251114FloPatch FP120DPW · Traditional Flosonics Medical06/20/2025SE
K243852Elfor-LDPW · Traditional Elfi-Tech , Ltd.04/14/2025SE
K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special Remington Medical, Inc.08/30/2024SE
K222242FloPatch FP120DPW · Traditional Flosonics Medical12/09/2022SE
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special Synovis Micro Companies Alliance, Inc.04/20/2022SE
K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional Remington Medical, Inc.01/27/2022SE
K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional Remington Medical, Inc.10/07/2021SE

More from Remington Medical, Inc.

510(k)DeviceDecision
K252810FloPatch FP120DPW · Special 04/24/2026SE
K251114FloPatch FP120DPW · Traditional 06/20/2025SE
K222242FloPatch FP120DPW · Traditional 12/09/2022SE

Questions and answers

When was FloPatch FP120 cleared by the FDA?

FloPatch FP120 (K223843) received a 510(k) decision of Substantially Equivalent on May 3, 2023, 132 days after the submission was received.

What is the product code of K223843?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.