# K030357: Quantix/or Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosonix, Ltd.
- Decided: Aug 20, 2003 after 198 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 2 (0 Class I)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 12 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)

## Most influential descendants
- K041180: Quantix or Vessel Stabilizer Device (2004), 1 descendant of its own
- K050088: Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer (2005), 0 descendants of its own

## Recalls of this device
- Dec 13, 2004 · Not classified · Z-0700-05: The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
- Dec 13, 2004 · Not classified · Z-0701-05: The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.

## Indications for use
Diagnostic blood flow measurements Intra-operative: For direct application to exposed blood vessel (miniature, sterilizable transducer)

Source page: https://510kreport.com/device/K030357
Methodology: https://510kreport.com/methodology