Cleared Traditional

K801233 - CELLTRIFUGE II (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801233 · Travenol Laboratories, S.A. · Hematology device
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Oct 1980
Decision
157d
Days
Class 2
Risk

K801233 is an FDA 510(k) clearance for the CELLTRIFUGE II. Classified as Separator, Automated, Blood Cell, Diagnostic (product code GKT), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 157 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9245 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K801233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date October 31, 1980
Days to Decision 157 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 113d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKT Separator, Automated, Blood Cell, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9245
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.