# K994008: Biosys Fetal Monitor, Model Ifm-500

- Pathway: 510(k) (Traditional)
- Applicant: Biosys Co., Ltd.
- Decided: Sep 29, 2000 after 310 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 K934959 (1994). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934959: Model 118 Fetal/Maternal Monitor, Ge Medical Systems Information Technologies (1994) Summary page 3.

## Most influential descendants
- K052190: Fetal Monitor, Models BT-300 and BT-200 (2005), 3 descendants of its own
- K100885: Fetal Monitor Model: BT-200T (2010), 1 descendant of its own
- K142799: Model BT-220L and BT-220C (2015), 0 descendants of its own
- K110612: FM20 (2011), 0 descendants of its own
- K110630: F10 (2011), 0 descendants of its own

## Indications for use
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.

Source page: https://510kreport.com/device/K994008
Methodology: https://510kreport.com/methodology