Cleared Traditional

SURGICAL ISOLATION BARRIER SYSTEM (K831531) - FDA 510(k) Clearance

K831531 · Lone Star Medical Products, Inc. · General & Plastic Surgery device
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Jun 1984
Decision
391d
Days
-
Risk

K831531 is an FDA 510(k) clearance for the SURGICAL ISOLATION BARRIER SYSTEM.

Submitted by Lone Star Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 5, 1984 after a review of 391 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K831531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date June 05, 1984
Days to Decision 391 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
276d slower than avg
Panel avg: 115d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -