Cleared Traditional

K760851 - CONVERSE ALTAR RETRACTOR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K760851 · V. Mueller O.V. Baxter Healthcare Corp. · Ear, Nose, Throat device
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Mar 1977
Decision
146d
Days
Class 1
Risk

K760851 is an FDA 510(k) clearance for the CONVERSE ALTAR RETRACTOR. Classified as Retractor, Ent (product code KAL), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 146 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date March 10, 1977
Days to Decision 146 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
57d slower than avg
Panel avg: 89d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAL Retractor, 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.