Cleared Traditional

K052878 - NT-1000

K052878 is an FDA 510(k) clearance for NT-1000, manufactured by Neuro Therm, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K052878 · Neuro Therm, Inc. · Neurology device
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Jan 2006
Decision
103d
Days
Class 2
Risk

K052878 is an FDA 510(k) clearance for the NT-1000. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Neuro Therm, Inc. (Middleton, US). The FDA issued a Cleared decision on January 23, 2006 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K052878

510(k) Number K052878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2005
Decision Date January 23, 2006
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 149d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 Neurology devices follow this clearance model.

Regulatory Peers - GXD Generator, Lesion, Radiofrequency

All 36
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K052878.
STOCKERT NEURO N50, MODEL12267
K070336 · Stockert GmbH · Jun 2007
STRYKER INTRADISCAL RF GENERATOR
K063489 · Synergetics, Inc. · May 2007
OWL URF-3AP
K062758 · Diros Technology, Inc. · Sep 2006
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
K040565 · Physician Industries, Inc. · Jul 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · Valley Forge Scientific Corp. · Apr 2004
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
K021869 · Diros Technology, Inc. · Jul 2002
K052878 · NT-1000
Download PDF Neuro Therm, Inc.