Cleared Traditional

K920782 - OLYMPIC TRANS-LITE (FDA 510(k) Clearance)

Class I General Hospital device.

K920782 · Olympic Medical Corp. · General Hospital
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Mar 1992
Decision
36d
Days
Class 1
Risk

K920782 is an FDA 510(k) clearance for the OLYMPIC TRANS-LITE. Classified as Light, Examination, Medical, Battery Powered (product code KYT), Class I - General Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6350 - the FDA general hospital device 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.

View all Olympic Medical Corp. devices

Submission Details

510(k) Number K920782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date March 27, 1992
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYT Light, Examination, Medical, Battery Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6350
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.