Cleared Traditional

K954449 - ENT PACKINGS

K954449 is an FDA 510(k) clearance for ENT PACKINGS, manufactured by Oasis. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K954449 · Oasis · Ear, Nose, Throat device
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Nov 1995
Decision
81d
Days
Class 1
Risk

K954449 is an FDA 510(k) clearance for the ENT PACKINGS, WICKS, WIPES, AND SPONGES. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Oasis (Glendora, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 81 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 Oasis devices

FDA 510(k) Submission Details - K954449

510(k) Number K954449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date November 14, 1995
Days to Decision 81 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 89d · This submission: 81d
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 K954449.
NASAL AIRWAY SPLINT
K972092 · Boston Medical Products, Inc. · Jul 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151 · Boston Medical Products, Inc. · Jul 1997
CUSTOM NASAL SPLINT
K972082 · Boston Medical Products, Inc. · Jul 1997
NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
BIVONA NASAL TURBINATE STENT
K935053 · Bivona Medical Technologies · Jul 1994
NASAL SEPTAL SPLINT
K921195 · Smith & Nephew Richards, Inc. · Jul 1992