# K002503: Fetalgard Lite

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Nov 9, 2000 after 87 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K043598: FC 1400 Fetal Monitor (2005), 1 descendant of its own
- K123335: Sunray Fetal Monitor (2013), 0 descendants of its own
- K051903: Fetalgard Lite-Nibp, Model FGL-Nibp (2005), 0 descendants of its own
- K050234: Remote Care (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K002503
Methodology: https://510kreport.com/methodology