# K102138: Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Oct 28, 2010 after 90 days
- Product code: MAA (Monitor, Fetal Doppler Ultrasound)
- 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.
5 later devices descend from it; 1 cites 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)
- K942441: Imexdop CT+, Imex Medical Systems, Inc. (1994) Summary page 1.
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular, Edan Instruments, Inc. (2008) Summary page 1.
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6, Edan Instruments, Inc. (2009) Summary page 1.

## Most influential descendants
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler (2016), 4 descendants of its own
- 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 Ultrasonic TableTop 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 through 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 MHz 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/K102138
Methodology: https://510kreport.com/methodology