Cleared Traditional

K792028 - OTOTOME BUR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K792028 · American Sterilizer Co. · Ear, Nose, Throat device
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Oct 1979
Decision
17d
Days
Class 1
Risk

K792028 is an FDA 510(k) clearance for the OTOTOME BUR. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - 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 American Sterilizer Co. devices

Submission Details

510(k) Number K792028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1979
Decision Date October 26, 1979
Days to Decision 17 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
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
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.