Cleared Special

K052795 - PHILIPS AVALON FETAL MONITOR

K052795 is the FDA 510(k) clearance for PHILIPS AVALON FETAL MONITOR by Philips Medizin Systeme Boeblingen GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Special 510(k) pathway after a 88-day FDA review.

K052795 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
88d
Days
Class 2
Risk

K052795 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on December 30, 2005 after a review of 88 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K052795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date December 30, 2005
Days to Decision 88 days
Submission Type Special
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
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 97
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K052795.
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
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc. · Sep 2004
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003