Cleared Traditional

K870451 - SKIN GRAFT PRESERVATION MEDIUM (TISSUE) (FDA 510(k) Clearance)

Class I Pathology device.

K870451 · Bioclinical Laboratory Services, Inc. · Pathology device
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May 1987
Decision
112d
Days
Class 1
Risk

K870451 is an FDA 510(k) clearance for the SKIN GRAFT PRESERVATION MEDIUM (TISSUE). Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Bioclinical Laboratory Services, Inc. (Clarence, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology device framework. 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioclinical Laboratory Services, Inc. devices

Submission Details

510(k) Number K870451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date May 26, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 77d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.