# K172780: SD1 Ultrasonic Pocket Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 6, 2018 after 265 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: 7 generations back to K930200 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131457: Fetal Ultrasonic Monitor and Accessories, Shenzhen Jumper Medical Equipment Co., Ltd. (2014) Summary page 4.
- K140579: Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2015) Summary page 4.

## Indications for use
The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.

Source page: https://510kreport.com/device/K172780
Methodology: https://510kreport.com/methodology