Cleared Traditional

K921285 - 9105 RIGID TELESCOPIC ENDOSCOPE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K921285 · Kay Elemetrics Corp. · Ear, Nose, Throat device
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May 1992
Decision
72d
Days
Class 1
Risk

K921285 is an FDA 510(k) clearance for the 9105 RIGID TELESCOPIC ENDOSCOPE. Classified as Laryngostroboscope (product code EQL), Class I - General Controls.

Submitted by Kay Elemetrics Corp. (Pine Brook, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4750 - the FDA ear, nose and throat 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 Kay Elemetrics Corp. devices

Submission Details

510(k) Number K921285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date May 28, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 89d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQL Laryngostroboscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4750
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.