Cleared Special

K073221 - CADENCE II (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K073221 · Edan Instruments, Inc. · Radiology device

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Dec 2007

Decision

43d

Days

Class 2

Risk

K073221 is an FDA 510(k) clearance for the CADENCE II. 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 December 28, 2007 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2740 - the FDA radiology and imaging software oversight 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	K073221 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 2007
Decision Date	December 28, 2007
Days to Decision	43 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

64d faster than avg

Panel avg: 107d · This submission: 43d

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 Radiology devices follow this clearance model.