Cleared Traditional

K162383 - Cadwell Sierra Summit

K162383 is an FDA 510(k) clearance for Cadwell Sierra Summit, manufactured by Cadwell Industries, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K162383 · Cadwell Industries, Inc. · Neurology device
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Mar 2017
Decision
188d
Days
Class 2
Risk

K162383 is an FDA 510(k) clearance for the Cadwell Sierra Summit, Cadwell Sierra Ascent. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 1, 2017 after a review of 188 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 Cadwell Industries, Inc. devices

FDA 510(k) Submission Details - K162383

510(k) Number K162383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2016
Decision Date March 01, 2017
Days to Decision 188 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
40d slower than avg
Panel avg: 148d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 23
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K162383.
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K930328 · Bio-Logic Systems Corp. · Jul 1993