# K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Aug 24, 2006 after 29 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K941811 (1994). 124 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 133 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.

## Most influential descendants
- K071800: Philips Avalon Fetal Monitors FM20 and FM30 (2007), 7 descendants of its own
- K100420: Philips Obtracevue Model SW Rev. G.00 (2010), 4 descendants of its own
- K092028: Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50 (2010), 3 descendants of its own
- K102958: Philips Avalon Fetal Monitor (2011), 2 descendants of its own
- K173941: IntelliSpace Perinatal Rev.K.00 (2018), 1 descendant of its own

## Recalls of this device
- Nov 23, 2009 · Not classified · Z-0549-2010: Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inhe
- Nov 23, 2009 · Not classified · Z-0550-2010: Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inhe

## Indications for use
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 the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. 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 and in antepartum testing areas.

Source page: https://510kreport.com/device/K062137
Methodology: https://510kreport.com/methodology