# K171865: F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: Farus, LLC
- Decided: Aug 24, 2017 after 63 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894277 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A, Philips Medical Systems, Inc. (2003) Summary page 4.

## Indications for use
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is designed for use in singleton pregnancies only. It is not intended for home use. The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and functioning as a connection for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers. The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces.

Source page: https://510kreport.com/device/K171865
Methodology: https://510kreport.com/methodology