Cleared Traditional

K951526 - TREBAY IRRGATED CUTTER BLADE

K951526 is an FDA 510(k) clearance for TREBAY IRRGATED CUTTER BLADE, manufactured by Trebay Medical Corp.. The device is a Class 1 Ear, Nose, Throat device with product code EQJ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K951526 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
39d
Days
Class 1
Risk

K951526 is an FDA 510(k) clearance for the TREBAY IRRGATED CUTTER BLADE. 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 May 12, 1995 after a review of 39 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

FDA 510(k) Submission Details - K951526

510(k) Number K951526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date May 12, 1995
Days to Decision 39 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
50d faster than avg
Panel avg: 89d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

EQJ Device Classification - Class 1, General Controls

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

All 10
Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K951526.
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
K950337 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
ESSENTIAL SHAVER SYSTEM
K953096 · Smith & Nephew Richards, Inc. · Jul 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
K946332 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
MICROMEDICS EAR, NOSE AND THROAT BURS
K895738 · Micromedics, Inc. · Dec 1989
OTOTOME BUR
K792028 · American Sterilizer Co. · Oct 1979