Cleared Traditional

K002828 - XPS NITRO SYSTEM

K002828 is the FDA 510(k) clearance for XPS NITRO SYSTEM by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K002828 · Xomed, Inc. · Ear, Nose, Throat device
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Oct 2000
Decision
36d
Days
Class 2
Risk

K002828 is an FDA 510(k) clearance for the XPS NITRO SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 17, 2000 after a review of 36 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, Inc. devices

Submission Details

510(k) Number K002828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date October 17, 2000
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
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 58
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K002828.
MODIFICATION TO XPS 3000 SYSTEM
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K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001
TURBO 7000 SHAVER AND DRILL CONSOLE
K992994 · Gyrus Ent LLC · Nov 1999
HUMMER TRAK SYSTEM
K990038 · Stryker Endoscopy · Feb 1999
PNEUMATIC CUTTER SYSTEM
K983050 · Surgical Laser Technologies, Inc. · Nov 1998