Cleared Traditional

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF (K893519) - FDA 510(k) Clearance

Class I Microbiology device.

K893519 · Statlabs, Inc. · Microbiology device
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Aug 1989
Decision
99d
Days
Class 1
Risk

K893519 is an FDA 510(k) clearance for the TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF. Classified as Automated Colony Counter (product code KZB), Class I - General Controls.

Submitted by Statlabs, Inc. (Franklin, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2170 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Statlabs, Inc. devices

Submission Details

510(k) Number K893519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date August 15, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZB Automated Colony Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2170
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.