# K043597: FC 700 Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Dec 16, 2005 after 352 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: 2 generations back to K852608 (1985). 3 ancestors in all.
1 later device descends 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)
- K991905: Corometrics Model 171 and 172 Fetal Monitor, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K123335: Sunray Fetal Monitor (2013), 0 descendants of its own

## Indications for use
FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus. it intended to be used by trained healthcare personnel. It is not intended for home use.

Source page: https://510kreport.com/device/K043597
Methodology: https://510kreport.com/methodology