Cleared Special

K082369 - CADENCE

K082369 is the FDA 510(k) clearance for CADENCE by Edan Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Special 510(k) pathway after a 81-day FDA review.

K082369 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Nov 2008
Decision
81d
Days
Class 2
Risk

K082369 is an FDA 510(k) clearance for the CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 81 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K082369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date November 07, 2008
Days to Decision 81 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
79d faster than avg
Panel avg: 160d · This submission: 81d
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 88
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K082369.
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K100420 · Philips Medizin Systeme Boeblingen GmbH · Jul 2010
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
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · Philips Medizin Systeme Boeblingen GmbH · May 2008
CADENCE II
K073221 · Edan Instruments, Inc. · Dec 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007