# K250777: Sonicaid Team3

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Sep 19, 2025 after 189 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: 8 generations back to K864318 (1987). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241368: Sonicaid Team3, Huntleigh Healthcare, Ltd. (2025) Summary page 5.

## Most influential descendants
- K253021: ANNE Maternal (2026), 0 descendants of its own

## Indications for use
The Team3 fetal monitors are indicated for use by trained healthcare professionals in noninvasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women with singleton or twin pregnancies from the 28th week of gestation, through to term and delivery. In cases of triplet, the Team3 fetal monitors are intended for use from 30th week of gestation through 35 weeks gestation. The devices are intended for use in clinical and hospital-type facilities. Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications: • Single, twin or triplet fetal heart rates by means of ultrasound • Uterine activity - externally sensed • Manual fetal movement detection - maternally identified using the event marker • Automatic fetal movement detection (defaults to OFF / Not for use in twin or triplet pregnancies) • Maternal heart rate and oxygen saturation via pulse oximetry • Maternal non-invasive blood pressure • The DAWES REDMAN Cardiotocography (CTC) analysis output - advises whether a number of defined criteria indicative of a normal cardiotocograph record has been met for singleton pregnancies but not for triplet pregnancies. It provides nonspecific analysis in twin pregnancies due to nonspecific fetal movement input Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following Physiological applications: • Single, twin or triplet fetal heart rates by means of ultrasound and/or FECG • Manual fetal movement detection - maternally identified using the event marker • Maternal heart rate via ECG electrodes • Uterine activity - externally or internally sensed • Maternal heart rate and oxygen saturation via pulse oximetry • Maternal non-invasive blood pressure

Source page: https://510kreport.com/device/K250777
Methodology: https://510kreport.com/methodology