Cleared Traditional

K921195 - NASAL SEPTAL SPLINT

K921195 is an FDA 510(k) clearance for NASAL SEPTAL SPLINT, manufactured by Smith & Nephew Richards, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K921195 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
133d
Days
Class 1
Risk

K921195 is an FDA 510(k) clearance for the NASAL SEPTAL SPLINT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 133 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 Smith & Nephew Richards, Inc. devices

FDA 510(k) Submission Details - K921195

510(k) Number K921195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date July 23, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 90d · This submission: 133d
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 37
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K921195.
NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
NASAL SPLINT
K945555 · Ultracell Medical Technologies, Inc. · Jan 1995
BIVONA NASAL TURBINATE STENT
K935053 · Bivona Medical Technologies · Jul 1994
TURBINATE NASAL SPLINT
K921202 · Smith & Nephew Richards, Inc. · Jul 1992
FLORET NASAL TAMPON
K830263 · Ritmed, Inc. · Mar 1983