# K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 11, 2008 after 60 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). 7 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040480: Sonotrax Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2004) Summary page 2.
- K024197: Lifedop Doppler, Summit Doppler Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6 (2009), 7 descendants of its own
- K102138: Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler (2010), 5 descendants of its own
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler (2016), 4 descendants of its own
- K101960: Sonotrax Series Ultrasonic Pocket Doppler (2010), 4 descendants of its own
- K140579: Ultrasonic Pocket Doppler (2015), 3 descendants of its own

## Indications for use
The 2 mHz and/ or 3 mHz obstetrical probes are indicated for the detection of fetal life from early gestation thru delivery. They can also be used to verify fetal heart viability. The 4 mHz and/ or 8 mHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease. The Sonotrax series of pocket dopplers are to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

Source page: https://510kreport.com/device/K080087
Methodology: https://510kreport.com/methodology