DPW · Class II · 21 CFR 870.2100

FDA Product Code DPW: Flowmeter, Blood, Cardiovascular

Leading manufacturers include Koven Technology, Inc., Transonic Systems, Inc. and Koven and Assoc., Inc..

139
Total
139
Cleared
165d
Avg days
1976
Since
Growing category - 6 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 143d avg (recent)

FDA 510(k) Cleared Flowmeter, Blood, Cardiovascular Devices (Product Code DPW)

139 devices
1–24 of 139
Cleared Oct 27, 2026
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
K261714
Transonic Systems, Inc.
Cardiovascular · 154d
Cleared Jul 08, 2026
BlueDop Vascular Expert
K260700
BlueDop Medical, Ltd.
Cardiovascular · 126d
Cleared Apr 24, 2026
FloPatch FP120
K252810
Flosonics Medical
Cardiovascular · 233d
Cleared Nov 20, 2025
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01)
K251904
Remington Medical, Inc.
Cardiovascular · 153d
Cleared Jun 20, 2025
FloPatch FP120
K251114
Flosonics Medical
Cardiovascular · 70d
Cleared Apr 14, 2025
Elfor-L
K243852
Elfi-Tech , Ltd.
General & Plastic Surgery · 119d
Cleared Aug 30, 2024
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01)
K241583
Remington Medical, Inc.
Cardiovascular · 88d
Cleared May 03, 2023
FloPatch FP120
K223843
Flosonics Medical
Cardiovascular · 132d
Cleared Dec 09, 2022
FloPatch FP120
K222242
Flosonics Medical
Cardiovascular · 136d
Cleared Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
K213974
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 121d
Cleared Jan 27, 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
K211589
Remington Medical, Inc.
Cardiovascular · 248d
Cleared Oct 07, 2021
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
K212065
Remington Medical, Inc.
Cardiovascular · 97d
Cleared Jan 05, 2021
Bidop 7
K201114
Koven Technology, Inc.
Cardiovascular · 253d
Cleared Mar 24, 2020
FloPatch (FP120)
K200337
Flosonics Medical (R/A 1929803 Ontario Corp.)
Cardiovascular · 42d
Cleared Jan 10, 2020
FlowMet
K192966
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574
Huntleigh Healthcare , Ltd.
Cardiovascular · 259d
Cleared Jun 21, 2019
FloPatch (FP110)
K191388
Flosonics Medical (R/A 1929803 Ontario Corp.)
Cardiovascular · 28d
Cleared Feb 27, 2019
FlowMet-R
K182494
Laser Associated Sciences, Inc.
Cardiovascular · 169d
Cleared Dec 14, 2018
iCertainty
K181269
Rfpi
General & Plastic Surgery · 214d
Cleared Jun 28, 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457
Deltex Medical Limited
Cardiovascular · 318d
Cleared May 05, 2016
PeriFlux6000
K152930
Perimed AB
Cardiovascular · 213d
Cleared Nov 06, 2015
CerOX
K150268
Or-Nim Medical , Ltd.
Cardiovascular · 275d
Cleared Jul 24, 2015
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
K150347
Deltex Medical Limited
Cardiovascular · 163d
Cleared Jul 23, 2015
TRANSONIC TISSUE PERFUSION MONITOR
K140740
Transonic Systems, Inc.
Cardiovascular · 485d

About Product Code DPW - Regulatory Context

510(k) Submission Activity

139 total 510(k) submissions under product code DPW since 1976, with 139 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DPW Product Code

FDA review times for DPW submissions have been consistent, averaging 143 days recently vs 166 days historically.

DPW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →