# K990642: Echoflow Doppler Blood Velocity Meter

- Pathway: 510(k) (Traditional)
- Applicant: Echocath, Inc.
- Decided: Sep 16, 1999 after 202 days
- Product code: JOP (Transducer, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 870.2880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861378 (1986). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861378: Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst, Ultramed, Inc. (1986) Summary page 1.
- K921377: P/Meter, Zertl Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K013803: Flowguard Device (2002), 4 descendants of its own
- 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
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as £15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe. The IOP10 transducer for the EchoFlow BVM-1 is intended to be used with that unit to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as +15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.

Source page: https://510kreport.com/device/K990642
Methodology: https://510kreport.com/methodology