Cleared Abbreviated

K071800 - PHILIPS AVALON FETAL MONITORS FM20 AND FM30

K071800 is an FDA 510(k) clearance for PHILIPS AVALON FETAL MONITORS FM20 AND FM30, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

K071800 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
87d
Days
Class 2
Risk

K071800 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL MONITORS FM20 AND FM30. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 27, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medizinsysteme Boeblingen GmbH, Cardiac AN devices

FDA 510(k) Submission Details - K071800

510(k) Number K071800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date September 27, 2007
Days to Decision 87 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 103
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K071800.
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · Philips Medizin Systeme Boeblingen GmbH · May 2008
CADENCE II
K073221 · Edan Instruments, Inc. · Dec 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K062137 · Philips Medizin Systeme Boeblingen GmbH · Aug 2006
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH · Dec 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005