Cleared Traditional

K881165 - SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (FDA 510(k) Clearance)

Class I Pathology device.

K881165 · Sakura Finetek U.S.A., Inc. · Pathology device
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Jul 1988
Decision
103d
Days
Class 1
Risk

K881165 is an FDA 510(k) clearance for the SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR. Classified as Processor, Tissue, Automated (product code IEO), Class I - General Controls.

Submitted by Sakura Finetek U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3875 - 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 Sakura Finetek U.S.A., Inc. devices

Submission Details

510(k) Number K881165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1988
Decision Date July 01, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 77d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IEO Processor, Tissue, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3875
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.