Cleared Traditional

K780281 - IMMUFUGE DISP. LINER (FDA 510(k) Clearance)

Class I Hematology device.

K780281 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Mar 1978
Decision
9d
Days
Class 1
Risk

K780281 is an FDA 510(k) clearance for the IMMUFUGE DISP. LINER. Classified as Centrifuge, Blood-bank For In Vitro Diagnostic Use (product code KSO), Class I - General Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9275 - 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 Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K780281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date March 02, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 113d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KSO Centrifuge, Blood-bank For In Vitro Diagnostic Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9275
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.