Cleared Traditional

K102958 - PHILIPS AVALON FETAL MONITOR (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102958 · Philips Medizin Systeme Boblingen GmbH · Obstetrics & Gynecology device
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Mar 2011
Decision
165d
Days
Class 2
Risk

K102958 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on March 18, 2011 after a review of 165 days - an extended review 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medizin Systeme Boblingen GmbH devices

Submission Details

510(k) Number K102958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date March 18, 2011
Days to Decision 165 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 160d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 213
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