Cleared Traditional

K122494 - POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K122494 · Hemostasis, LLC · Ear, Nose, Throat device
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Mar 2013
Decision
223d
Days
Class 1
Risk

K122494 is an FDA 510(k) clearance for the POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on March 27, 2013 after a review of 223 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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.

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Submission Details

510(k) Number K122494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2012
Decision Date March 27, 2013
Days to Decision 223 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 89d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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.