Cleared Traditional

PLOTTER MODEL (MP100) (K861905) - FDA 510(k) Clearance

K861905 · Madsen Electronics (Canada) , Ltd. · Gastroenterology & Urology device
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Nov 1986
Decision
194d
Days
-
Risk

K861905 is an FDA 510(k) clearance for the PLOTTER MODEL (MP100).

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on November 26, 1986 after a review of 194 days - an extended review cycle.

This device falls under the Gastroenterology & Urology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K861905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date November 26, 1986
Days to Decision 194 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 130d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -