# K140535: Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizin Systeme Boblingen GmbH
- Decided: Nov 25, 2014 after 266 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K941811 (1994). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111083: Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 5.
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A, Philips Medical Systems, Inc. (2003) Summary page 5.

## Recalls of this device
- May 26, 2026 · Class II · Z-2523-2026: Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
- May 26, 2026 · Class II · Z-2522-2026: Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
- May 22, 2024 · Class II · Z-2239-2024: Potential for inaccurate fetal heart rate measurements when monitoring multiples.
- Sep 19, 2019 · Class II · Z-0985-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Sep 19, 2019 · Class II · Z-0984-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.

## Indications for use
Avalon Fetal/Maternal 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, oxygen saturation, noninvasive blood pressure, pulse rate and temperature 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 FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature 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 FM40: 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, noninvasive blood pressure, pulse rate and temperature 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 FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature 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/K140535
Methodology: https://510kreport.com/methodology