Cleared Traditional

K884493 - HEAD HOLDING DEVICE/SLEEP APNEA (FDA 510(k) Clearance)

Class I Radiology device.

K884493 · X-Ray Systems · Radiology device
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Jan 1989
Decision
78d
Days
Class 1
Risk

K884493 is an FDA 510(k) clearance for the HEAD HOLDING DEVICE/SLEEP APNEA. Classified as Holder, Head, Radiographic (product code IWY), Class I - General Controls.

Submitted by X-Ray Systems (Fraser, US). The FDA issued a Cleared decision on January 12, 1989 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1920 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K884493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1988
Decision Date January 12, 1989
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWY Holder, Head, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.