# K092028: Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Feb 17, 2010 after 226 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: 21 generations back to K941811 (1994). 126 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052795: Philips Avalon Fetal Monitor, Models FM20 and FM30, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2.
- K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2.
- K071800: Philips Avalon Fetal Monitors FM20 and FM30, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 2.

## Most influential descendants
- K102958: Philips Avalon Fetal Monitor (2011), 2 descendants of its own
- K111083: Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 (2011), 1 descendant of its own
- K140535: Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 (2014), 0 descendants of its own

## Indications for use
Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households. Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and th-e-fetaTr-heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households. Avalon Fetal Monitor FM4O: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine, activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal Monitor FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, EGG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Source page: https://510kreport.com/device/K092028
Methodology: https://510kreport.com/methodology