# K112657: Aureflo Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Dec 21, 2011 after 99 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872048 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040228: Medi-Stim Veriq System, Model VQ1001 - VQ4122, Medi-Stim A/S (2004) Summary page 1.

## Indications for use
The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts: where surgery is medically indicated; intraoperatively, rather than in chronic implant: at intraoperative sites which admit and retain ultrasonic couplant: with minimal vessel manipulation or constriction (to avoid vessel spasm): where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

Source page: https://510kreport.com/device/K112657
Methodology: https://510kreport.com/methodology