# K180419: Ultrasonic Doppler (Model YM-2T8)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
- Decided: Jul 19, 2018 after 154 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). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler, Edan Instruments, Inc. (2016) Summary page 4.

## Most influential descendants
- K182710: Fetal Doppler, Model FD88 (2019), 0 descendants of its own
- K182190: Fetal Doppler (2018), 0 descendants of its own

## Indications for use
The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.

Source page: https://510kreport.com/device/K180419
Methodology: https://510kreport.com/methodology