Cleared Traditional

K102263 - HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0

K102263 is an FDA 510(k) clearance for HORIZON PERINATAL CARE SURVEILLANCE AND..., manufactured by Mckesson Information Solutions, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K102263 · Mckesson Information Solutions, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
268d
Days
Class 2
Risk

K102263 is an FDA 510(k) clearance for the HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Mckesson Information Solutions, LLC (Philedelphia, US). The FDA issued a Cleared decision on May 5, 2011 after a review of 268 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.

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FDA 510(k) Submission Details - K102263

510(k) Number K102263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date May 05, 2011
Days to Decision 268 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
108d slower than avg
Panel avg: 160d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 123
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K102263.
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FETAL MONITORS, MODELS F2 AND F3
K102140 · Edan Instruments, Inc. · Jan 2011
CENTRAL MONITORING SYSTEM
K100358 · Edan Instruments, Inc. · Jan 2011
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc. · Nov 2010