Cleared Traditional

K945659 - BLACKSTAR(TM) STAR SYSTEM

K945659 is the FDA 510(k) clearance for BLACKSTAR(TM) STAR SYSTEM by Xomed-Treace, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K945659 · Xomed-Treace, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
53d
Days
Class 2
Risk

K945659 is an FDA 510(k) clearance for the BLACKSTAR(TM) STAR SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - 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 Xomed-Treace, Inc. devices

Submission Details

510(k) Number K945659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date January 09, 1995
Days to Decision 53 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
36d faster than avg
Panel avg: 89d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 39
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K945659.
INTRAARC DRIVE SYSTEM
K951263 · Linvatec Corp. · Apr 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · Stryker Corp. · Jan 1995
APEX UNIVERSAL DRIVE SYSTEM
K944476 · Linvatec Corp. · Nov 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · Treace Medical, Inc. · Sep 1987