# K101960: Sonotrax Series Ultrasonic Pocket Doppler

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 10, 2010 after 29 days
- Product code: HEP (Monitor, Blood-Flow, Ultrasonic)
- 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: 4 generations back to K930200 (1994). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular, Edan Instruments, Inc. (2008) Summary page 1.

## Most influential descendants
- K140579: Ultrasonic Pocket Doppler (2015), 3 descendants of its own
- K191388: FloPatch (FP110) (2019), 1 descendant of its own
- K242487: Laminar P1 (LDH-HW-001) (2024), 0 descendants of its own
- K172780: SD1 Ultrasonic Pocket Doppler (2018), 0 descendants of its own

## Indications for use
The Sonotrax Series Ultrasonic Pocket Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MLHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Source page: https://510kreport.com/device/K101960
Methodology: https://510kreport.com/methodology