# K043598: FC 1400 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: 1 generation back to K002503 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002503: Fetalgard Lite, Analogic Corp. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A, Philips Medical Systems, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

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

## Indications for use
FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Twelve hours of tracing may be stored and later retrieved for printing. It intended to be used by trained healthcare personnel. It is not intended for home use.

Source page: https://510kreport.com/device/K043598
Methodology: https://510kreport.com/methodology