# K050088: Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer

- Pathway: 510(k) (Special)
- Applicant: Neoprobe Corp.
- Decided: Feb 8, 2005 after 26 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: 5 generations back to K851426 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013803: Flowguard Device, Biosonix, Ltd. (2002). Our reading of the summary gave K018303, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “FlowGuard probe”.
- K030357: Quantix/or Device, Cardiosonix, Ltd. (2003) Summary page 1.
- K041180: Quantix or Vessel Stabilizer Device, Cardiosonix, Ltd. (2004) Summary page 1.
- K992305: Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004, Medi-Stim A/S (1999) Summary page 1.
- K872048: Transonic Flowmeter, Transonic Systems, Inc. (1988) Summary page 1.

## Indications for use
The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.

Source page: https://510kreport.com/device/K050088
Methodology: https://510kreport.com/methodology