# K082480: Contec Pocket Fetal  Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Feb 25, 2009 after 181 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: 3 generations back to K930200 (1994). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024197: Lifedop Doppler, Summit Doppler Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K100626: Doppler Fetal Heart Rate Detector, Model FM-200 (2010), 9 descendants of its own
- K112911: Fetal Doppler (2011), 8 descendants of its own
- K131457: Fetal Ultrasonic Monitor and Accessories (2014), 6 descendants of its own
- K182526: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) (2019), 4 descendants of its own
- K220245: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (2022), 1 descendant of its own

## Indications for use
Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type. SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2Mlz water proof probe,3MHz normal probe,3'Ml-lz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

Source page: https://510kreport.com/device/K082480
Methodology: https://510kreport.com/methodology