# K992607: Sonicaid System 8002

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Instruments Medical Systems
- Decided: Apr 27, 2001 after 633 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: 1 generation back to K912639 (1991). 1 ancestor in all.
28 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912639: Sonicaid Team, Oxford Medilog, Inc. (1991) Summary page 2.

## Most influential descendants
- K081140: Visensia (2008), 22 descendants of its own
- K110953: Visensia, Visensia with Alert (2011), 17 descendants of its own
- K152258: T3 Software (2016), 16 descendants of its own
- K163065: T3 Software (2017), 15 descendants of its own
- K190273: T3 Platform software (2019), 14 descendants of its own

## Indications for use
The Sénicaid System 8002 is for use in pregnancies from 32 weeks gestation onwards. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following: — previous questionable fetal heart rate recordings or poor obstetric history _ abnormal umbilical blood flow velocity waveforms — suspected fetal anomalies — suspicion of maternal intoxication or assault — intrauterine growth retardation — antepartum haemorrhage — uterine pain — reduced fetal movements — hypertension or pre-eclampsia — reduced amniotic fluid volume The Sonicaid System 8002 is used as an adjunct to and is not intended to replace or substitute for assessment of amniotic fluid amount, Doppler evaluations, and/or biophysical profile.

Source page: https://510kreport.com/device/K992607
Methodology: https://510kreport.com/methodology