# K013803: Flowguard Device

- Pathway: 510(k) (Traditional)
- Applicant: Biosonix, Ltd.
- Decided: Feb 13, 2002 after 90 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: 2 generations back to K851426 (1985). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892707: DVM-4200 Blood Flowmeter, Koven and Assoc., Inc. (1989) Summary page 1.
- K990642: Echoflow Doppler Blood Velocity Meter, Echocath, Inc. (1999) Summary page 1.
- K972798: Dynemo 3000, Sometec, Inc. (1998) Summary page 1.

## Most influential descendants
- K030357: Quantix/or Device (2003), 2 descendants of its own
- 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
- K023431: Quantix/ND Device (2002), 0 descendants of its own

## Indications for use
Diagnostic blood flow measurements

Source page: https://510kreport.com/device/K013803
Methodology: https://510kreport.com/methodology