# K024197: Lifedop Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Summit Doppler Systems, Inc.
- Decided: Jan 3, 2003 after 14 days
- Product code: KNG (Monitor, Ultrasonic, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.2660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930200 (1994). 2 ancestors in all.
31 later devices descend from it; 7 cite it directly.
0 of 34 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 1.
- K991441: Cadence Doppler Ultrasound System, Medasonics, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K112911: Fetal Doppler (2011), 8 descendants of its own
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6 (2009), 7 descendants of its own

## Recalls of this device
- Oct 6, 2017 · Class II · Z-1131-2018: The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

## Indications for use
Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Source page: https://510kreport.com/device/K024197
Methodology: https://510kreport.com/methodology