Cleared Traditional

K925173 - BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT

K925173 is an FDA 510(k) clearance for BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT, manufactured by Westmed Intl.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K925173 · Westmed Intl. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
93d
Days
Class 1
Risk

K925173 is an FDA 510(k) clearance for the BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 93 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.

FDA 510(k) Submission Details - K925173

510(k) Number K925173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1992
Decision Date January 15, 1993
Days to Decision 93 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
3d slower than avg
Panel avg: 90d · This submission: 93d
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 45
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K925173.
BIVONA NASAL TURBINATE STENT
K935053 · Bivona Medical Technologies · Jul 1994
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658 · Merocel Corp. · Mar 1994
MEROCEL MEROSPLINT
K933152 · Merocel Corp. · Aug 1993
NASAL SEPTAL SPLINT
K921195 · Smith & Nephew Richards, Inc. · Jul 1992
TURBINATE NASAL SPLINT
K921202 · Smith & Nephew Richards, Inc. · Jul 1992
INVOTEC BI-VALVE SPLINT
K901306 · Invotec International, Inc. · Jun 1990
K925173 · BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
Download PDF FDA Summary Westmed Intl.