# K112529: TD-5000 & TD-6000 Ultrasonic Tabletop Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Oct 27, 2011 after 57 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6, Edan Instruments, Inc. (2009) Summary page 2.

## 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 thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Source page: https://510kreport.com/device/K112529
Methodology: https://510kreport.com/methodology