Cleared Traditional

K960421 - SINUSCAN 102/SINUSPRINT (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960421 · Ferguson Medical · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
443d
Days
Class 2
Risk

K960421 is an FDA 510(k) clearance for the SINUSCAN 102/SINUSPRINT. Classified as Ultrasound, Sinus (product code LWI), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

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Submission Details

510(k) Number K960421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date April 16, 1997
Days to Decision 443 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 107d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWI Ultrasound, Sinus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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.