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Philips Avalon Fetal Monitors FM20 and FM30

by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

510(k) K071800

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK071800 Date27 Sep 2007ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0549-2010 FDA Unclassified (pre-2012) initiated 23 Nov 2009
    • Terminated Z-0550-2010 FDA Unclassified (pre-2012) initiated 23 Nov 2009

    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 inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous generation Philips Series 50 fetal monitors. Clinical decisions bas

  • 2 recalls, same reason

    • Terminated Z-1478-2009 FDA Unclassified (pre-2012) initiated 12 May 2009
    • Terminated Z-1479-2009 FDA Unclassified (pre-2012) initiated 12 May 2009

    Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Philips Avalon Fetal Monitors FM20 and FM30 are systems for monitoring perinatal parameters, designed for noninvasive monitoring of pregnant women during antepartum testing and labor and delivery. They measure fetal and maternal heart rates separately and incorporate automated coincidence detection (cross-channel verification) using Smart Pulse technology to enhance diagnostic confidence.

These devices are supplied as reusable monitors intended for use in clinical settings such as antepartum and intrapartum settings. They connect to the IntelliSpace Perinatal system to support the continuum of care from antepartum visits through delivery, postpartum, and newborn nursery follow-up. The device has received FDA 510(k) clearance under K071800 and is classified as a Class II medical device under regulation number 884.2740.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Philips Avalon FM20 and FM30 fetal monitor used for?

    The Philips Avalon FM20 and FM30 are designed for noninvasive monitoring of pregnant women during antepartum testing and labor and delivery, measuring fetal and maternal heart rates separately using Smart Pulse technology for automated coincidence detection to enhance diagnostic confidence.

  • Is the Philips Avalon FM20 and FM30 fetal monitor reusable or single-use?

    The Philips Avalon FM20 and FM30 are supplied as reusable monitors intended for use in clinical settings such as antepartum and intrapartum environments, meaning they are designed for repeated use after proper cleaning and disinfection between patients.

  • How does the Philips Avalon FM20 and FM30 connect to other systems for perinatal care?

    The Philips Avalon FM20 and FM30 connect to the IntelliSpace Perinatal system to support the continuum of care from antepartum visits through delivery, postpartum, and newborn nursery follow-up, enabling integrated data management across care stages.