Cleared Traditional

CASTLE WASHER/DISINFECTOR, MODEL 7550 (K911087) - FDA 510(k) Clearance

K911087 · Mdt Biologic Co. · General & Plastic Surgery device
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Aug 1993
Decision
882d
Days
-
Risk

K911087 is an FDA 510(k) clearance for the CASTLE WASHER/DISINFECTOR, MODEL 7550.

Submitted by Mdt Biologic Co. (Rochester, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 882 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K911087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date August 09, 1993
Days to Decision 882 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
767d slower than avg
Panel avg: 115d · This submission: 882d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -