# K002548: Fetal Assist

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Diagnostics, Ltd.
- Decided: Mar 6, 2001 after 201 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
No predicates in its family tree.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020390: Modification to Fetal Assist (2002), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K002548
Methodology: https://510kreport.com/methodology