Cleared Traditional

NASAL/EPISTAXIS PACK (K113585) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K113585 · Cogent Therapeutics, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
142d
Days
Class 1
Risk

K113585 is an FDA 510(k) clearance for the NASAL/EPISTAXIS PACK. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Cogent Therapeutics, LLC (Pleasanton, US). The FDA issued a Cleared decision on April 25, 2012 after a review of 142 days - within the typical 510(k) review window.

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.

View all Cogent Therapeutics, LLC devices

Submission Details

510(k) Number K113585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date April 25, 2012
Days to Decision 142 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
53d slower than avg
Panel avg: 89d · This submission: 142d
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.

Regulatory Peers - LYA Splint, Intranasal Septal

All 45
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K113585.
TurbAlign
K243655 · Spirair, Inc. · Jul 2025
Epi-Stop Nasal Gel/epistaxis pack
K230142 · Biomed Ent, Inc. · Mar 2023
SPIWay Endonasal Access Guide
K213153 · Spiway, LLC · Oct 2021
Novapak Nasal Sinus Packing and Stent
K202623 · Medtronic Xomed · Dec 2020
ChitoZolve
K181696 · Gyrus Acmi, Inc. · Nov 2018
SPIWay Endonasal Access Guide
K180141 · Spiway, LLC · Feb 2018