Cleared Traditional

K981374 - POREX NOSTRIL RETAINERS

K981374 is an FDA 510(k) clearance for POREX NOSTRIL RETAINERS, manufactured by Porex Surgical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K981374 · Porex Surgical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
77d
Days
Class 1
Risk

K981374 is an FDA 510(k) clearance for the POREX NOSTRIL RETAINERS. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Porex Surgical, Inc. (College Park, US). The FDA issued a Cleared decision on July 2, 1998 after a review of 77 days - a notably fast clearance 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: 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 Porex Surgical, Inc. devices

FDA 510(k) Submission Details - K981374

510(k) Number K981374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date July 02, 1998
Days to Decision 77 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
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K981374.
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004
SEPRAGEL SINUS
K012532 · Genzyme Corp. · Oct 2001
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc. · Apr 2001
BIVALVE NASAL SPLINT
K972096 · Boston Medical Products, Inc. · Jul 1997
NASAL AIRWAY SPLINT
K972092 · Boston Medical Products, Inc. · Jul 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151 · Boston Medical Products, Inc. · Jul 1997