Cleared Traditional

K111614 - CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE

K111614 is an FDA 510(k) clearance for CENTRICITY PERINATAL AND CENTRICITY INT..., manufactured by Ge Healthcare Integrated IT Solutions. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K111614 · Ge Healthcare Integrated IT Solutions · Obstetrics & Gynecology device
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Sep 2011
Decision
110d
Days
Class 2
Risk

K111614 is an FDA 510(k) clearance for the CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Healthcare Integrated IT Solutions (Barrington, US). The FDA issued a Cleared decision on September 26, 2011 after a review of 110 days - within the typical 510(k) review window.

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 Ge Healthcare Integrated IT Solutions devices

FDA 510(k) Submission Details - K111614

510(k) Number K111614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date September 26, 2011
Days to Decision 110 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 161d · This submission: 110d
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 177
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K111614.
OBIX PERINATAL DATA SYSTEM 7.0
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FM-9000 PLUS FETAL AND MATERNAL MONITOR
K112317 · Advanced Instrumentations, Inc. · Dec 2011
FM20
K110612 · Mediana Co., Ltd. · Nov 2011
CMS-1000FM CENTRAL MONITORING SYSTEM
K112159 · Advanced Instrumentations, Inc. · Sep 2011
FM-1000 PLUS FETAL MONITOR
K112187 · Advanced Instrumentations, Inc. · Sep 2011
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K111083 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2011