# K991441: Cadence Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medasonics, Inc.
- Decided: Dec 28, 1999 after 246 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: 1 generation back to K930200 (1994). 1 ancestor in all.
44 later devices descend from it; 5 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930200: Multi Dopplex II / Fetal Dopplex II, Huntleigh Healthcare, Inc. (1994) Summary page 2.
- (no number) Medasonics Incorporated Models FP3B and BF4B: named in the summary without a submission number

## Most influential descendants
- K024197: Lifedop Doppler (2003), 31 descendants of its own
- K040480: Sonotrax Ultrasonic Pocket Doppler (2004), 21 descendants of its own
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular (2008), 13 descendants of its own
- K082480: Contec Pocket Fetal  Doppler (2009), 12 descendants of its own
- K100626: Doppler Fetal Heart Rate Detector, Model FM-200 (2010), 9 descendants of its own

## Indications for use
Using the 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being. Using the 5.1 Mhz probe: Detection of blood flow in the peripheral vascular system of the body

Source page: https://510kreport.com/device/K991441
Methodology: https://510kreport.com/methodology