Cleared Traditional

K042208 - ISIS MER SYSTEM/ELEKTA MER SYSTEM

K042208 is an FDA 510(k) clearance for ISIS MER SYSTEM/ELEKTA MER SYSTEM, manufactured by Inomed Medizintechnik GmbH. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K042208 · Inomed Medizintechnik GmbH · Neurology device
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Mar 2005
Decision
214d
Days
Class 2
Risk

K042208 is an FDA 510(k) clearance for the ISIS MER SYSTEM/ELEKTA MER SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Inomed Medizintechnik GmbH (Stockholm, DE). The FDA issued a Cleared decision on March 18, 2005 after a review of 214 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

View all Inomed Medizintechnik GmbH devices

FDA 510(k) Submission Details - K042208

510(k) Number K042208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date March 18, 2005
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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.