# K023431: Quantix/ND Device

- Pathway: 510(k) (Special)
- Applicant: Cardiosonix, Ltd.
- Decided: Nov 13, 2002 after 29 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 K851426 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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)

## Indications for use
Diagnostic Blood Flow.Measurements Diagnostic Blood Flow Measurements

Source page: https://510kreport.com/device/K023431
Methodology: https://510kreport.com/methodology