# K090285: Sonicaid FM820 and FM830 Encore

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Jul 15, 2009 after 160 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: 5 generations back to K864318 (1987). 14 ancestors in all.
4 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)
- K002150: Sonicaid FM820, Sonicaid FM830, Oxford Instruments (2001) Summary page 2.
- K082718: Tempusic Patient Monitor, Remote Diagnostic Technologies, Ltd. (2008) Summary page 2.

## Most influential descendants
- K200975: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (2020), 3 descendants of its own
- K241368: Sonicaid Team3 (2025), 2 descendants of its own
- K250777: Sonicaid Team3 (2025), 1 descendant of its own
- K253021: ANNE Maternal (2026), 0 descendants of its own

## Indications for use
The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or in transport monitoring applications. Sonicaid FM820E is suitable for use when there is a need to monitor the following physiological parameters: * Single or twin fetal heart rates by means of ultrasound * Fetal or maternal heart rate via ECG Uterine activity - externally or internally sensed * Fetal movement - maternally sensed. Sonicaid FM830E is suitable for use when there is a need to monitor the following physiological parameters: * Single or twin fetal heart rates by means of ultrasound Fetal or maternal heart rate via ECG Uterine activity - externally or internally sensed * Fetal movement - maternally sensed. Maternal heart rate and oxygen saturation via pulse oximetry * Maternal non-invasive blood pressure

Source page: https://510kreport.com/device/K090285
Methodology: https://510kreport.com/methodology