# K153475: SD5 & SD6 Ultrasonic Tabletop Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 29, 2016 after 58 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: 6 generations back to K930200 (1994). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102138: Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler, Edan Instruments, Inc. (2010) Summary page 10.

## Most influential descendants
- K180419: Ultrasonic Doppler (Model YM-2T8) (2018), 2 descendants of its own
- K212084: Fetal Doppler (2021), 0 descendants of its own
- K182710: Fetal Doppler, Model FD88 (2019), 0 descendants of its own
- K182190: Fetal Doppler (2018), 0 descendants of its own

## Indications for use
The SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop Doppler (hereinafter called “SD6”) 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 obstetrical 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.

Source page: https://510kreport.com/device/K153475
Methodology: https://510kreport.com/methodology