# K140579: Ultrasonic Pocket Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 6, 2015 after 337 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: 5 generations back to K930200 (1994). 9 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K101960: Sonotrax Series Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2010) Summary page 4.

## Most influential descendants
- 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 SD3 Series Ultrasonic Pocket Dopplers (hereinafter called “the Doppler”) are 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 waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability. The 4 MHz, 5 MHz and/or 8 MHz waterproof 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/K140579
Methodology: https://510kreport.com/methodology