Cleared Traditional

BARRIER INTEGRITY MONITOR (K915662) - FDA 510(k) Clearance

K915662 · Incomed, Inc. · General & Plastic Surgery device
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Jun 1992
Decision
190d
Days
-
Risk

K915662 is an FDA 510(k) clearance for the BARRIER INTEGRITY MONITOR.

Submitted by Incomed, Inc. (San Diego, US). The FDA issued a Cleared decision on June 25, 1992 after a review of 190 days - an extended review cycle.

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 Incomed, Inc. devices

Submission Details

510(k) Number K915662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date June 25, 1992
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -