Cleared Traditional

K842090 - RHINO-LARYNX STROBOSCOPE TYPE 4914 (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K842090 · Bruel & Kjaer Industri A/S · Ear, Nose, Throat device
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Jul 1984
Decision
55d
Days
Class 1
Risk

K842090 is an FDA 510(k) clearance for the RHINO-LARYNX STROBOSCOPE TYPE 4914. Classified as Laryngostroboscope (product code EQL), Class I - General Controls.

Submitted by Bruel & Kjaer Industri A/S (Walker, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 55 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 Bruel & Kjaer Industri A/S devices

Submission Details

510(k) Number K842090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1984
Decision Date July 18, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 89d · This submission: 55d
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.