Cleared Traditional

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 (K854533) - FDA 510(k) Clearance

K854533 · Madsen Electronics (Canada) , Ltd. · Neurology device
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Sep 1986
Decision
321d
Days
-
Risk

K854533 is an FDA 510(k) clearance for the SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on September 30, 1986 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel. 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K854533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date September 30, 1986
Days to Decision 321 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 148d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -