Cleared Traditional

K091251 - CERNER FETALINK (VERSION 1.0)

K091251 is an FDA 510(k) clearance for CERNER FETALINK (VERSION 1.0), manufactured by Cerner Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K091251 · Cerner Corp. · Obstetrics & Gynecology device
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Aug 2009
Decision
118d
Days
Class 2
Risk

K091251 is an FDA 510(k) clearance for the CERNER FETALINK (VERSION 1.0). Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Cerner Corp. (Kansas City, US). The FDA issued a Cleared decision on August 25, 2009 after a review of 118 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 Cerner Corp. devices

FDA 510(k) Submission Details - K091251

510(k) Number K091251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date August 25, 2009
Days to Decision 118 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 160d · This submission: 118d
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 116
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K091251.
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PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
K092028 · Philips Medizin Systeme Boeblingen GmbH · Feb 2010
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · Edan Instruments, Inc. · Nov 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc. · Nov 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · Philips Medizin Systeme Boeblingen GmbH · May 2008