# K132650: Sonicaid Freedom Wireless Fetal Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare Limited
- Decided: Feb 7, 2014 after 165 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 1.

## Indications for use
The Sonicaid"' Freedom Wireless Fetal Monitoring System ('Freedomn') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy. It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid' FMS2O and FM830 Encore Fetal Monitors ('FMBOOE Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors: * Uterine activity by using an external, pressure-sensitive TOCO transducer, and * Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer. Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment. This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who istrained in the use of FHR monitors.

Source page: https://510kreport.com/device/K132650
Methodology: https://510kreport.com/methodology