Cleared Traditional

PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (K850333) - FDA 510(k) Clearance

Class I Hematology device.

K850333 · Shaban Mfg. Co. · Hematology device
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Feb 1985
Decision
30d
Days
Class 1
Risk

K850333 is an FDA 510(k) clearance for the PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Shaban Mfg. Co. (Fort Myers, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3800 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shaban Mfg. Co. devices

Submission Details

510(k) Number K850333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date February 27, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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.