Cleared Traditional

K870451 - SKIN GRAFT PRESERVATION MEDIUM (TISSUE)

K870451 is an FDA 510(k) clearance for SKIN GRAFT PRESERVATION MEDIUM (TISSUE), manufactured by Bioclinical Laboratory Services, Inc.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K870451

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.

KIT Device Classification - Class 1, General Controls

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.

Regulatory Peers - KIT Media And Components, Synthetic Cell And Tissue Culture

All 336
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K870451.
MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)
K873028 · J R Scientific · Aug 1987
GIT SERUM-FREE MEDIUM FOR CELL CULTURE
K872918 · Wako Chemicals USA, Inc. · Aug 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K872465 · J R Scientific · Jul 1987
INTRA-ARTICULATED ARTHRO POWER SYSTEM
K871250 · Richard Wolf Medical Instruments Corp. · Apr 1987
(DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE
K871191 · Sigma Chemical Co. · Apr 1987
HL-1 SUPPLEMENT
K870876 · Ventrex Laboratories, Inc. · Mar 1987