Cleared Special

CADENCE II (K073221) - 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 27
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K073221.
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MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993