Cleared Traditional

K893519 - TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

K893519 is an FDA 510(k) clearance for TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFU..., manufactured by Statlabs, Inc.. The device is a Class 1 Microbiology device with product code KZB cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K893519

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.

KZB Device Classification - Class 1, General Controls

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.