Product code GKT— Hematology

FDA has cleared 10 devices under product code GKT between 1977 and 2020, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20201 clearance
• 20161 clearance
• 19822 clearances
• 19801 clearance
• 19793 clearances
• 19772 clearances

• Travenol Laboratories, S.A.2 clearances
• Intl. Business Machines2 clearances
• Terumo America, Inc.1 clearance
• Pheragen Technology Corp.1 clearance
• Metrix Teknika, Inc.1 clearance
• Fresenius Kabi USA,Llc1 clearance
• Fresenius Kabi AG1 clearance
• Cryosan, Inc.1 clearance

Death

167

Injury

301

Malfunction

2,086

Total

2,554

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K200530 — AMICUS Separator SystemFresenius Kabi AG·2020-09-11
• K162462 — AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc·2016-11-23
• K822521 — AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.·1982-09-30
• K820396 — AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.·1982-04-27
• K801233 — CELLTRIFUGE IITravenol Laboratories, S.A.·1980-10-31
• K791106 — STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.·1979-08-10
• K790105 — TERUMO IMUGARDTerumo America, Inc.·1979-05-24
• K781803 — FILTER, EYRPUR DISPOSABLE LEUKOCITEMetrix Teknika, Inc.·1979-01-17
• K771258 — BLOOD CELL SEPARATOR 2997Intl. Business Machines·1977-09-06
• K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991Intl. Business Machines·1977-01-10