Cleared Traditional

K910781 - #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K910781 · Midmark Corp. · Ear, Nose, Throat device
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May 1991
Decision
79d
Days
Class 1
Risk

K910781 is an FDA 510(k) clearance for the #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - 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 Midmark Corp. devices

Submission Details

510(k) Number K910781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date May 15, 1991
Days to Decision 79 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
10d faster than avg
Panel avg: 89d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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.