# K111083: Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decided: Aug 17, 2011 after 120 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K941811 (1994). 187 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102958: Philips Avalon Fetal Monitor, Philips Medizin Systeme Boblingen GmbH (2011) Summary page 1.
- K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90  Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 1.
- K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 1.
- K100420: Philips Obtracevue Model SW Rev. G.00, Philips Medizin Systeme Boeblingen GmbH (2010) Summary page 1.

## Most influential descendants
- K140535: Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 (2014), 0 descendants of its own

## Recalls of this device
- Oct 3, 2014 · Class II · Z-0105-2015: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

## Indications for use
Avalon Fetal/Maternal Monitor FM2O: 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, 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, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM3O: 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 the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal 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/Maternal Monitor FM5O: 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 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/K111083
Methodology: https://510kreport.com/methodology