Cleared Traditional

MIRROR, LARYNGEAL (K770053) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K770053 · Welch Allyn, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1977
Decision
8d
Days
Class 1
Risk

K770053 is an FDA 510(k) clearance for the MIRROR, LARYNGEAL. Classified as Mirror, Ent (product code KAI), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K770053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1977
Decision Date January 18, 1977
Days to Decision 8 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
81d faster than avg
Panel avg: 89d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAI Mirror, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.