Cleared Traditional

TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K954912 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
44d
Days
Class 1
Risk

K954912 is an FDA 510(k) clearance for the TREBAY IRRIGATED CUTTER BLADE (MODIFICATION). Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - 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 Trebay Medical Corp. devices

Submission Details

510(k) Number K954912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date December 06, 1995
Days to Decision 44 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
45d faster than avg
Panel avg: 89d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
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 - EQJ Bur, Ear, Nose And Throat

Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K954912.
Precision Thin Reciprocating Blade, 0.010in.
K161514 · Stryker Corporation · Jan 2017
KARL STORZ ENT SHAVER
K953370 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
K950337 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
K946332 · KARL STORZ Endoscopy-America, Inc. · Jun 1995