Cleared Traditional

K791681 - THE DENVER SPLINT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K791681 · Xomed, Inc. · Ear, Nose, Throat device
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Oct 1979
Decision
55d
Days
Class 1
Risk

K791681 is an FDA 510(k) clearance for the THE DENVER SPLINT. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on October 22, 1979 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5800 - 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 Xomed, Inc. devices

Submission Details

510(k) Number K791681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1979
Decision Date October 22, 1979
Days to Decision 55 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
34d faster than avg
Panel avg: 89d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPP Splint, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5800
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.