Cleared Traditional

K843148 - KODAK T-MAT H FILM SO-118 (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K843148 · Eastman Kodak Company · Cardiovascular device
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Aug 1984
Decision
17d
Days
Class 3
Risk

K843148 is an FDA 510(k) clearance for the KODAK T-MAT H FILM SO-118. Classified as Tissue Graft Of Less Than 6mm (product code LWZ), Class III - Premarket Approval.

Submitted by Eastman Kodak Company (Walker, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K843148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date August 27, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWZ Tissue Graft Of Less Than 6mm
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.