# K023143: Echo Sounder, ES-102EX

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Dec 19, 2002 after 90 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: 2 generations back to K930200 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942441: Imexdop CT+, Imex Medical Systems, Inc. (1994) Summary page 1.
- K991441: Cadence Doppler Ultrasound System, Medasonics, Inc. (1999) Summary page 1.
- K010889: Baby Dopplex 3000 MK 2 (BD3000), Huntleigh Healthcare, Inc. (2001) Summary page 1.

## Most influential descendants
- K031504: Echo Sounder, Single-Handed, Model ES-101EX (2003), 0 descendants of its own

## Indications for use
Detection of fetal heart rate, detection of multiple pregnancies. Veri@ fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.

Source page: https://510kreport.com/device/K023143
Methodology: https://510kreport.com/methodology