Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9245](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9245) → GKT — Separator, Automated, Blood Cell, Diagnostic

# GKT · Separator, Automated, Blood Cell, Diagnostic

_Hematology · 21 CFR 864.9245 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT

## Overview

- **Product Code:** GKT
- **Device Name:** Separator, Automated, Blood Cell, Diagnostic
- **Regulation:** [21 CFR 864.9245](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9245)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.

## Classification Rationale

Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”

## Special Controls

*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K200530](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K200530.md) | AMICUS Separator System | Fresenius Kabi AG | Sep 11, 2020 | SESE |
| [K162462](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K162462.md) | AMICUS Separator System, AMICUS Separator System; Refurbished | Fresenius Kabi USA,Llc | Nov 23, 2016 | SESE |
| [K822521](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K822521.md) | AUTOMATED BLOOD CELL SEPARATOR | Cryosan, Inc. | Sep 30, 1982 | SESE |
| [K820396](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K820396.md) | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | Pheragen Technology Corp. | Apr 27, 1982 | SESE |
| [K801233](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K801233.md) | CELLTRIFUGE II | Travenol Laboratories, S.A. | Oct 31, 1980 | SESE |
| [K791106](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K791106.md) | STERILE, DISPOSABLE CENTRIFUGE BOWL | Travenol Laboratories, S.A. | Aug 10, 1979 | SESE |
| [K790105](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K790105.md) | TERUMO IMUGARD | Terumo America, Inc. | May 24, 1979 | SESE |
| [K781803](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K781803.md) | FILTER, EYRPUR DISPOSABLE LEUKOCITE | Metrix Teknika, Inc. | Jan 17, 1979 | SESE |
| [K771258](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K771258.md) | BLOOD CELL SEPARATOR 2997 | Intl. Business Machines | Sep 6, 1977 | SESE |
| [K760856](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT/K760856.md) | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Intl. Business Machines | Jan 10, 1977 | SESE |

## Top Applicants

- Intl. Business Machines — 2 clearances
- Travenol Laboratories, S.A. — 2 clearances
- Cryosan, Inc. — 1 clearance
- Fresenius Kabi AG — 1 clearance
- Fresenius Kabi USA,Llc — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/GKT)

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