# K030466: Handydop

- Pathway: 510(k) (Abbreviated)
- Applicant: Elcat, GmbH
- Decided: Sep 12, 2003 after 212 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991441: Cadence Doppler Ultrasound System, Medasonics, Inc. (1999) Summary page 1.

## Most influential descendants
- K060064: Stethoflux (2006), 0 descendants of its own

## Indications for use
HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body. When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease

Source page: https://510kreport.com/device/K030466
Methodology: https://510kreport.com/methodology