Cleared Traditional

K922287 - E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS

K922287 is an FDA 510(k) clearance for E.Z. PORT(TM) RADIATION THERAPY SKIN MA..., manufactured by I.Z.I. Corp.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K922287 · I.Z.I. Corp. · Radiology device
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Oct 1992
Decision
154d
Days
Class 2
Risk

K922287 is an FDA 510(k) clearance for the E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by I.Z.I. Corp. (Owings Mills, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 154 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all I.Z.I. Corp. devices

FDA 510(k) Submission Details - K922287

510(k) Number K922287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date October 16, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 38
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K922287.
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