510(k) · Cleared
Recalled · Class II · 2025Medistim Veriqc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Stim Asa · DPW Flowmeter, Blood, Cardiovascular
Cleared on Dec 27, 2010 as substantially equivalent to K040228 (Medi-Stim A/S, 2004) and 1 other predicate after a 109-day review. Its family tree reaches back 3 generations to 1988. It has been recalled once.
- Decided
- Dec 27, 2010
- Review
- 109 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872048 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872048 Transonic FlowmeterTransonic Systems, Inc. · 1988 · Recalled
- 2 generations backK992305 Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999
- 1 generation backK040228 Medi-Stim Veriq System, Model VQ1001 - VQ4122Medi-Stim A/S · 2004 · Recalled
- This deviceK102595 Medistim Veriqc SystemMedi-Stim Asa · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872048 | Transonic Flowmeter | Transonic Systems, Inc. | 1988 | 10 |
| −2 | K992305 | Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 | Medi-Stim A/S | 1999 | — |
| −1 | K040228 | Medi-Stim Veriq System, Model VQ1001 - VQ4122 | Medi-Stim A/S | 2004 | 1 |
| 0 (this device) | K102595 | Medistim Veriqc System | Medi-Stim Asa | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040228 | Medi-Stim Veriq System, Model VQ1001 - VQ4122Summary page 1…Ultrasound Transducer '892.1570 ITX Equivalent Device Identification: The MediStim VeriQC is substantially equivalent to the MediStim VeriQ model VQ4122 (K040228) manufactured by MediStim ASA, Fernanda Nissensgate 3, N-0484 OSLO, with added features equivalent to the GE Vivid 7 Diagnostic U… | 2004 |
| * | K041552 | GE Vivid 7 BT04Summary page 1…MediStim ASA, Fernanda Nissensgate 3, N-0484 OSLO, with added features equivalent to the GE Vivid 7 Diagnostic Ultrasound System with Diagnostic ultrasound transducers (K04 1552) manufactured by GE Medical systems, Ultrasound and Care Diagnostics, LLC PO Box 414, Milwaukee, WI 53201. Device… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0410-2026 | Process control | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K040228.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully pian and accomplish surgical interventions." The clinical indications for the device are: I. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery. 2. Simultaneous measurements of blood pressure, vascular…
Read the full statement (132 words)
The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully pian and accomplish surgical interventions." The clinical indications for the device are:
I. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.
2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
4. Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
5. Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102595: Medistim Veriqc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102595
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026