# K983395: Fetalgard 3000 Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Aug 12, 1999 after 321 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 K950420 (1995). 1 ancestor in all.
3 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)
- K950420: Fetalgard 3000 - Models IP1, IP2, AP2 and AP3, Analogic Corp. (1995) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. This data is intended to aid in assessing the well-being of the fetus during pregnancy, labor, and delivery.

Source page: https://510kreport.com/device/K983395
Methodology: https://510kreport.com/methodology