Cleared Traditional

K881165 - SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR

K881165 is an FDA 510(k) clearance for SAKURA HEM-480 ELECTRON MICROSCOPY PROC..., manufactured by Sakura Finetek U.S.A., Inc.. The device is a Class 1 Pathology device with product code IEO cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K881165 · Sakura Finetek U.S.A., Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K881165

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.

IEO Device Classification - Class 1, General Controls

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.

Regulatory Peers - IEO Processor, Tissue, Automated

All 11
Devices cleared under the same product code (IEO) and FDA review panel - the closest regulatory comparables to K881165.
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K834599 · Technicon Instruments Corp. · Feb 1984