# K040228: Medi-Stim Veriq System, Model VQ1001 - VQ4122

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Stim A/S
- Decided: Apr 29, 2004 after 87 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872048 (1988). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992305: Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004, Medi-Stim A/S (1999) Summary page 2.
- K010452: BI-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300T, Koven Technology, Inc. (2002)
- K903026: ES-1000SP II Smart Dop, Koven and Assoc., Inc. (1991) Summary page 2.

## Most influential descendants
- K112657: Aureflo Monitoring System (2011), 0 descendants of its own
- K102595: Medistim Veriqc System (2010), 0 descendants of its own

## Recalls of this device
- Apr 25, 2017 · Class II · Z-0719-2018: A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

## Indications for use
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 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.

Source page: https://510kreport.com/device/K040228
Methodology: https://510kreport.com/methodology