Cleared Traditional

K781750 - MIRROR WARMER

K781750 is an FDA 510(k) clearance for MIRROR WARMER, manufactured by Arleton Technical Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KAI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K781750 · Arleton Technical Products, Inc. · Ear, Nose, Throat device
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Jan 1979
Decision
93d
Days
Class 1
Risk

K781750 is an FDA 510(k) clearance for the MIRROR WARMER. Classified as Mirror, Ent (product code KAI), Class I - General Controls.

Submitted by Arleton Technical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Arleton Technical Products, Inc. devices

FDA 510(k) Submission Details - K781750

510(k) Number K781750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1978
Decision Date January 17, 1979
Days to Decision 93 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
4d slower than avg
Panel avg: 89d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

KAI Device Classification - Class 1, General Controls

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.