# K040480: Sonotrax Ultrasonic Pocket Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 25, 2004 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). 5 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010889: Baby Dopplex 3000 MK 2 (BD3000), Huntleigh Healthcare, Inc. (2001) Summary page 2.
- K991441: Cadence Doppler Ultrasound System, Medasonics, Inc. (1999) Summary page 2.
- K942441: Imexdop CT+, Imex Medical Systems, Inc. (1994) Summary page 2.
- K023618: Sonicaid One, Oxford Instruments Medical, Ltd. (2003) Summary page 2.

## Most influential descendants
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular (2008), 13 descendants of its own
- 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

## Indications for use
Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate.

Source page: https://510kreport.com/device/K040480
Methodology: https://510kreport.com/methodology