# K020390: Modification to Fetal Assist

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Diagnostics, Ltd.
- Decided: Apr 19, 2002 after 72 days
- Product code: LQK (Home Uterine Activity Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2730
- 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 K002548 (2001). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002548: Fetal Assist, Huntleigh Diagnostics, Ltd. (2001) Summary page 1.

## Most influential descendants
- K143114: Sense4Baby System Model B+ (MSA) (2015), 4 descendants of its own
- K210025: INVU by Nuvo (2021), 1 descendant of its own
- K253673: M•care System (MW-20) (2026), 0 descendants of its own
- K221046: Invu by Nuvo (2022), 0 descendants of its own
- K191401: PregSense (2020), 0 descendants of its own

## Indications for use
The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications from a gestation age of approximately 26 weeks. It is particularly intended for use in the following specific areas: Antenatal monitoring in the hospital, doctors office, health clinic, home or community. External Labour monitoring. Waterbirth monitoring using optional waterproof transducers. Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the daily at-home measurement of uterine activity for women with a history of preterm birth. Domiciliary Non Stress Testing applications. The FETAL ASSIST is a prescription device.

Source page: https://510kreport.com/device/K020390
Methodology: https://510kreport.com/methodology