Cleared Traditional

K011321 - MODIFICATION TO XPS 3000 SYSTEM

K011321 is an FDA 510(k) clearance for MODIFICATION TO XPS 3000 SYSTEM, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K011321 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Jun 2001
Decision
60d
Days
Class 2
Risk

K011321 is an FDA 510(k) clearance for the MODIFICATION TO XPS 3000 SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 26, 2001 after a review of 60 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 Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K011321

510(k) Number K011321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2001
Decision Date June 26, 2001
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

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 K011321.
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · Gyrus Ent LLC · Mar 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · Stryker Instruments · Mar 2004
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · Gyrus Ent LLC · Mar 2002
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · Stryker Instruments · May 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001
XPS NITRO SYSTEM
K002828 · Xomed, Inc. · Oct 2000