# K950420: Fetalgard 3000 - Models IP1, IP2, AP2 and AP3

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: May 15, 1995 after 104 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; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983395: Fetalgard 3000 Fetal Monitor (1999), 3 descendants of its own
- K090145: Surecall Emg Labor Monitor (2011), 2 descendants of its own
- K131889: Eum 100PRO (2014), 0 descendants of its own
- K130002: Surecall Labor Monitor (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K950420
Methodology: https://510kreport.com/methodology