Cleared Traditional

K893811 - SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K893811 · Sakura Finetek U.S.A., Inc. · Chemistry device
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Sep 1989
Decision
108d
Days
Class 1
Risk

K893811 is an FDA 510(k) clearance for the SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Sakura Finetek U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on September 7, 1989 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Sakura Finetek U.S.A., Inc. devices

Submission Details

510(k) Number K893811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date September 07, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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.