# K110612: FM20

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Nov 8, 2011 after 250 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 K934959 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994008: Biosys Fetal Monitor, Model Ifm-500, Biosys Co., Ltd. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K052196: Vilex X-Fix, Vilex, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The FM2O is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 podt to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.

Source page: https://510kreport.com/device/K110612
Methodology: https://510kreport.com/methodology