# K123335: Sunray Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sunray Medical Apparatus Co., Ltd.
- Decided: Mar 21, 2013 after 146 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: 3 generations back to K852608 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043597: FC 700 Fetal Monitor, Bionet Co., Ltd. (2005) Summary page 2.
- K043598: FC 1400 Fetal Monitor, Bionet Co., Ltd. (2005) Summary page 2.

## Indications for use
SRF61 885 Fetal Monitor detects and displays single or twin (optional) 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. Ten hours of tracing may be stored and later retrieved for printing. It is intended for antepartumn use by trained healthcare personnel. It is not intended for home use. Diagnostic ultrasound imaging or fluid flow analysis of the human body for antepartumn use as follows:

Source page: https://510kreport.com/device/K123335
Methodology: https://510kreport.com/methodology