| K-number | K250777 |
| Device name | Sonicaid Team3 |
| Applicant | Huntleigh Healthcare , Ltd. |
| Product code | HGM |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 884.2740 |
The Sonicaid Team3 is a fetal monitoring system for use by trained healthcare professionals to monitor physiological parameters in pregnant women and fetuses during pregnancy. It performs noninvasive and invasive monitoring of fetal heart rate, uterine activity, maternal vital signs, and other parameters in singleton, twin, and triplet pregnancies from 28 weeks gestation (or 30 weeks for triplets) through delivery in clinical and hospital settings.
The subject device is identical to the predicate device except for the addition of a third ultrasound transducer port on the monitor's front panel. This enables simultaneous monitoring of three independent fetal heart rates using the same directional pulsed Doppler ultrasound technology, maintaining the same 30-240 bpm range and ±2 bpm accuracy as the two-channel predicate system.
EN 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1 (electrical safety), and manufacturer-defined acceptance criteria for ultrasound performance testing. Clinical validation was performed per user requirements verification methodology.
The subject device has identical technological characteristics, materials, software, and intended use as the predicate device (K241368), differing only in the addition of a third ultrasound channel for triplet monitoring. Bench testing demonstrated accurate and simultaneous detection of three fetal heart rates across the full operating range with performance within predefined acceptance criteria, and clinical validation in 8 patients confirmed correct display, acceptable trace quality, and acceptable audio performance with no safety or effectiveness concerns identified.
View the full FDA submission: accessdata.fda.gov