# K013376: Qflow 500 Perfusion Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hemedex Incorporated
- Decided: May 8, 2002 after 209 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 K875179 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903633: Advance Laser Flowmeter, Alf 21, Transonic Systems, Inc. (1990) Summary page 1.
- K896515: Laserflo Blood Perfusion Monitor, Model BPM2, Tsi, Inc. (1990) Summary page 1.
- K951832: Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433, Vasamedics, LLC (1996) Summary page 1.
- K962700: Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit, Vasamedics, LLC (1997) Summary page 1.
- K961368: Trimflo Parenchymal Blood Flow Monitoring Probe Kit, Vasamedics, LLC (1996) Summary page 1.

## Indications for use
The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.

Source page: https://510kreport.com/device/K013376
Methodology: https://510kreport.com/methodology