Panels › Cardiovascular › Product code DPW · Class 2
Flowmeter, Blood, Cardiovascular
Regulation 870.2100
3510(k)s in 12 months (138 all time)
1recalls in 12 months (35 all time)
31recalls that name a 510(k)
Top companies in DPW
| Company | 510(k)s | Recalls |
|---|---|---|
| Transonic Systems, Inc. | 5 | 10 |
| Koven Technology, Inc. | 7 | 1 |
| Baxter Healthcare Corp. | 0 | 7 |
| Vascular Technology Incorporated | 2 | 5 |
| Deltex Medical | 6 | 0 |
| Perimed AB | 6 | 0 |
| Koven and Assoc., Inc. | 5 | 0 |
| Parks Medical Electronics Inc | 0 | 5 |
| Cardio Metrics, Inc. | 4 | 0 |
| Flosonics Medical | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Koven Technology, Inc. Brand Name: BiDop 3
Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe
Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe).
Software Version: N/A
Product Des Open, Classified |
DPW | K954397 |
| Oct 29, 2025 | Medistim Asa Brand Name: Medistim MiraQ System
Product Name: Medistim MiraQ System
Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011
Software Version: Not applicable
Product Description: Ultrasound devi Open, Classified |
DPW | K102595 |
| Sep 4, 2025 | Flosonics Medical (R/A 1929803 ONTARIO CORP.) FloPatch FP120, REF: FP120-FOT01-005 Open, Classified |
DPW | K200337 K223843 |
| Jul 20, 2023 | Baxter Healthcare Corporation GEM FLOW COUPLER Monitor, PN 5156-00000-011 Open, Classified |
DPW | K191252 |
| Jun 19, 2018 | Vascular Technology, Inc. VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel
Ref. Number: 108910
Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic Terminated |
DPW | K031091 |
| Apr 25, 2017 | Medistim Asa MEDISTIM VERIQ SYSTEM, MODEL VQ4122
An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. Terminated |
DPW | K040228 |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to Terminated |
DPW | K143589 |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to- Terminated |
DPW | K132727 K143589 |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to Terminated |
DPW | K132727 |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-t Terminated |
DPW | K132727 |
| Apr 21, 2016 | Baxter Healthcare Corp. GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC
Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to Terminated |
DPW | K132727 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQC3MP --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQC2MP --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Jul 29, 2014 | Baxter Healthcare Corporation FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstr Terminated |
DPW | K132727 |
| Jul 7, 2014 | Vascular Technology, Inc. VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Dec 10, 2012 | Parks Medical Electronics, Inc Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessor Terminated |
DPW | K944495 |
| Oct 22, 2010 | Escalon Medical Corp PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146:
Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in g Terminated |
DPW | K903625 |
| Jul 3, 2008 | Parks Medical Electronics Inc Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 Terminated |
DPW | None listed |
| Jul 3, 2008 | Parks Medical Electronics Inc Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 Terminated |
DPW | None listed |
| Jul 3, 2008 | Parks Medical Electronics Inc Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 Terminated |
DPW | None listed |
| Jul 3, 2008 | Parks Medical Electronics Inc Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 Terminated |
DPW | None listed |
| Jun 3, 2005 | Philips Ultrasound, Inc. Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) Terminated |
DPW | K002186 |
| Apr 13, 2005 | Neoprobe Corp Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. Terminated |
DPW | K030357 |
| Apr 13, 2005 | Neoprobe Corp Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. Terminated |
DPW | K030357 |
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