# K031504: Echo Sounder, Single-Handed, Model ES-101EX

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Jul 18, 2003 after 65 days
- Product code: KNG (Monitor, Ultrasonic, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.2660
- 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 K930200 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023143: Echo Sounder, ES-102EX, Koven Technology, Inc. (2002)

## Indications for use
Detection of fetal life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.

Source page: https://510kreport.com/device/K031504
Methodology: https://510kreport.com/methodology