Cleared Traditional

K790105 - TERUMO IMUGARD

K790105 is an FDA 510(k) clearance for TERUMO IMUGARD, manufactured by Terumo America, Inc.. The device is a Class 2 Hematology device with product code GKT cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K790105 · Terumo America, Inc. · Hematology device
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May 1979
Decision
128d
Days
Class 2
Risk

K790105 is an FDA 510(k) clearance for the TERUMO IMUGARD. Classified as Separator, Automated, Blood Cell, Diagnostic (product code GKT), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 24, 1979 after a review of 128 days - within the typical 510(k) review window.

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 - K790105

510(k) Number K790105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1979
Decision Date May 24, 1979
Days to Decision 128 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
15d slower than avg
Panel avg: 113d · This submission: 128d
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 K790105.
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
K820396 · Pheragen Technology Corp. · Apr 1982
CELLTRIFUGE II
K801233 · Travenol Laboratories, S.A. · Oct 1980
STERILE, DISPOSABLE CENTRIFUGE BOWL
K791106 · Travenol Laboratories, S.A. · Aug 1979
FILTER, EYRPUR DISPOSABLE LEUKOCITE
K781803 · Metrix Teknika, Inc. · Jan 1979
BLOOD CELL SEPARATOR 2997
K771258 · Intl. Business Machines · Sep 1977
BLOOD CELL PROCESSOR MODEL 2 IBM 2991
K760856 · Intl. Business Machines · Jan 1977
K790105 · TERUMO IMUGARD
Download PDF Terumo America, Inc.