# K241368: Sonicaid Team3

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Feb 3, 2025 after 265 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: 7 generations back to K864318 (1987). 16 ancestors in all.
2 later devices descend 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)
- K200975: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum, Huntleigh Healthcare Limited (2020) Summary page 5.

## Most influential descendants
- K250777: Sonicaid Team3 (2025), 1 descendant of its own
- 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 non-invasive 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 from the 28th week of gestation, through to term and delivery. 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 or twin fetal heart rates by means of ultrasound - Uterine activity - externally sensed - Fetal movement - maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure - CTG analysis - advises whether a number of defined criteria indicative of a normal cardiograph record has been met Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound and/or FECG - Maternal heart rate via ECG electrodes - Uterine activity - externally or internally sensed - Fetal movement - maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure

Source page: https://510kreport.com/device/K241368
Methodology: https://510kreport.com/methodology