510(k) · Cleared

Recalled · Class II · 2017

Medi-Stim Veriq System, Model VQ1001 - VQ4122

K040228510(k) TraditionalCleared Apr 29, 200487-day reviewClass II21 CFR 870.2100Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medi-Stim A/S · DPW Flowmeter, Blood, Cardiovascular

Cleared on Apr 29, 2004 as substantially equivalent to K992305 (Medi-Stim A/S, 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it. It has been recalled once.

Decided: Apr 29, 2004
Review: 87 days
Class: Class II
Product code: DPW
Recalls: 1
Predicates: 3

Its longest line of descent runs back 2 generations to K872048 (1988). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK872048 Transonic FlowmeterTransonic Systems, Inc. · 1988 · Recalled
1 generation backK992305 Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999
This deviceK040228 Medi-Stim Veriq System, Model VQ1001 - VQ4122Medi-Stim A/S · 2004
Descendant · cites it directly · 0 of its ownK112657 Aureflo Monitoring SystemTransonic Systems, Inc. · 2011
Descendant · cites it directly · 0 of its ownK102595 Medistim Veriqc SystemMedi-Stim Asa · 2010 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K112657Aureflo Monitoring SystemTransonic Systems, Inc. · 2011 · cites it directly0descendants
K102595Medistim Veriqc SystemMedi-Stim Asa · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K872048	Transonic Flowmeter	Transonic Systems, Inc.	1988	10
−1	K992305	Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004	Medi-Stim A/S	1999	—
0 (this device)	K040228	Medi-Stim Veriq System, Model VQ1001 - VQ4122	Medi-Stim A/S	2004	—
+1	K112657	Aureflo Monitoring System	Transonic Systems, Inc.	2011	—
+1	K102595	Medistim Veriqc System	Medi-Stim Asa	2010	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0

FIG. 1 — Lineage of K040228, 1988–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K992305	Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 Summary page 2 …Page 96 Predicate Devices: Medi-Stim AS Medi-Stim Butterfly Flowmeter (K992305) Koven Technology, Inc. Doppler Flowmieter DVM-4300T (KO 10452)…	Medi-Stim A/S	1999	—
*	K010452	BI-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300T	Koven Technology, Inc.	2002	—
*	K903026	ES-1000SP II Smart Dop Summary page 2 …Koven Technology, Inc. Doppler Flowmieter DVM-4300T (KO 10452) Doppler Flownmeter ES- I OOOSPM Smartdop (K903026) 12125 Woodcrest Executive Drive, Suite 220 St. Louis, MO 6314…	Koven and Assoc., Inc.	1991	—

Also cleared against K992305: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112657	Aureflo Monitoring System	Transonic Systems, Inc.	2011	0
K102595	Medistim Veriqc System	Medi-Stim Asa	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 25, 2017	Class II	Z-0719-2018	Nonconforming Material/Component	A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K112657 (Transonic Systems, Inc., 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K992305.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPW

3in 2025

2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2007high 275 (2015) · low 89 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPW

1in 2025

2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPW

6in 2025

2007high 12 (2015) · low 0 (2007)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 VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are: 1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-surgery. 2. Simultaneous measurements of blood pressure, vascular resistance, interfaced…

Read the full statement (126 words)

1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-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/K040228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040228: Medi-Stim Veriq System, Model VQ1001 - VQ4122.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040228

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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