Cleared Traditional

K801233 - CELLTRIFUGE II

K801233 is an FDA 510(k) clearance for CELLTRIFUGE II, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Hematology device with product code GKT cleared through the Traditional 510(k) pathway after a 157-day FDA review.

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.

FDA 510(k) Submission Details - K801233

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
Combination Product No
PCCP Authorized No
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.

GKT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GKT Separator, Automated, Blood Cell, Diagnostic

All 9
Devices cleared under the same product code (GKT) and FDA review panel - the closest regulatory comparables to K801233.
AMICUS Separator System, AMICUS Separator System
K162462 · Fresenius Kabi USA,Llc · Nov 2016
AUTOMATED BLOOD CELL SEPARATOR
K822521 · Cryosan, Inc. · Sep 1982
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
K820396 · Pheragen Technology Corp. · Apr 1982
STERILE, DISPOSABLE CENTRIFUGE BOWL
K791106 · Travenol Laboratories, S.A. · Aug 1979
TERUMO IMUGARD
K790105 · Terumo America, Inc. · May 1979
FILTER, EYRPUR DISPOSABLE LEUKOCITE
K781803 · Metrix Teknika, Inc. · Jan 1979
K801233 · CELLTRIFUGE II
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