Cleared Traditional

K952655 - B & L ELECTRODE

K952655 is an FDA 510(k) clearance for B & L ELECTRODE, manufactured by B & L Engineering. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K952655 · B & L Engineering · Neurology device
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Sep 1995
Decision
143d
Days
Class 2
Risk

K952655 is an FDA 510(k) clearance for the B & L ELECTRODE. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by B & L Engineering (Santa Fe Springs, US). The FDA issued a Cleared decision on September 28, 1995 after a review of 143 days - within the typical 510(k) review window.

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 B & L Engineering devices

FDA 510(k) Submission Details - K952655

510(k) Number K952655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date September 28, 1995
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
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 43
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K952655.
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EXCEL EMG
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PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
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K893130 · Bio-Logic Systems Corp. · Mar 1990