# K052795: Philips Avalon Fetal Monitor, Models FM20 and FM30

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Dec 30, 2005 after 88 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: 18 generations back to K941811 (1994). 123 ancestors in all.
9 later devices descend from it; 3 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)
- K954351: Series 50XM, Hewlett-Packard GmbH (1996) Summary page 2.
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2.
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boblingen GmbH (2004) Summary page 2.
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2.
- K051366: Piconibp Oem Module, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 3.
- K030973: Picosat II SPO2 Pulse Oximetry Module, Philips Medical Systems (2003) Summary page 3.
- K033715: Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server, Philips Medical Systems, Inc. (2004) Summary page 3.
- K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T, Philips Medical Systems, Inc. (2004) Summary page 3.
- K042306: Philips SP02 Disposable Sensor, Model M1131A, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 3.
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System, Hewlett-Packard GmbH (1997) Summary page 3.
- K954955: Storc Intrauterine Pressure Catheter, Clinical Innovations, Inc. (1996) Summary page 3.

## Most influential descendants
- K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30 (2006), 8 descendants of its own
- 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

## Recalls of this device
- 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 rate 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 rate in labor and delivery rooms and in antepartum testing areas.

Source page: https://510kreport.com/device/K052795
Methodology: https://510kreport.com/methodology