Cleared Traditional

DRESSING CHANGE TRAY STERILE 5002 (K842404) - FDA 510(k) Clearance

K842404 · Pro-Lab, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
168d
Days
-
Risk

K842404 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY STERILE 5002.

Submitted by Pro-Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 168 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.

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Submission Details

510(k) Number K842404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date December 04, 1984
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -