# K031931: Echo Sounder EX-101EX 8 MHZ

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Feb 13, 2004 after 235 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: 1 generation back to K915550 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915550: Mini Doppler II Ultrasound Blood Flow Detector, Koven and Assoc., Inc. (1992) Summary page 1.

## Indications for use
Evaluation of blood flow in patients with peripheral vascular disease, heart sounds and rates.

Source page: https://510kreport.com/device/K031931
Methodology: https://510kreport.com/methodology