Cleared Traditional

SOLUMBRA SUN PROTECTIVE CLOTHING (K920240) - FDA 510(k) Clearance

K920240 · Wetmore Assoc., Inc. · General & Plastic Surgery device
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May 1992
Decision
117d
Days
-
Risk

K920240 is an FDA 510(k) clearance for the SOLUMBRA SUN PROTECTIVE CLOTHING.

Submitted by Wetmore Assoc., Inc. (Seattle, US). The FDA issued a Cleared decision on May 13, 1992 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Wetmore Assoc., Inc. devices

Submission Details

510(k) Number K920240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date May 13, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MIW
Device Class -