GKTFDA Class 2 · 21 CFR 864.9245
Separator, Automated, Blood Cell, Diagnostic
Device family · Hematology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
10
Manufacturers
2
Flagged signals
13
Adverse-event reports
5,528
Code matrix
| FDA product code | GKT |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9245 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2011 | 6 | 40.3 | 193 |
| Other | 2011 | 4 | 26.9 | 76 |
| Other | 2012 | 4 | 26.9 | 76 |
| Other | 2010 | 3 | 20.2 | 37 |
| 2012 | 6 | 18.2 | 81 | |
| Death | 2021 | 20 | 4.5 | 52 |
| Death | 2025 | 3 | 4.3 | 5 |
| Death | 2020 | 18 | 4.1 | 39 |
| Death | 2019 | 18 | 4.1 | 39 |
| Death | 2022 | 16 | 3.6 | 28 |
| Death | 2024 | 16 | 3.6 | 28 |
| Death | 2023 | 12 | 2.7 | 12 |
| Death | 2018 | 10 | 2.3 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 5,528 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Travenol Laboratories, S.A. | 2 | 1980 | — |
| Fresenius Kabi AG | 1 | 2020 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
AMICUS Separator System · Fresenius Kabi AG510(k) · 2020-09-11
AMICUS Separator System, AMICUS Separator System; Refurbished · Fresenius Kabi USA,Llc510(k) · 2016-11-23
AUTOMATED BLOOD CELL SEPARATOR · Cryosan, Inc.510(k) · 1982-09-30
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR · Pheragen Technology Corp.510(k) · 1982-04-27
CELLTRIFUGE II · Travenol Laboratories, S.A.510(k) · 1980-10-31
STERILE, DISPOSABLE CENTRIFUGE BOWL · Travenol Laboratories, S.A.510(k) · 1979-08-10
TERUMO IMUGARD · Terumo America, Inc.510(k) · 1979-05-24
FILTER, EYRPUR DISPOSABLE LEUKOCITE · Metrix Teknika, Inc.510(k) · 1979-01-17
BLOOD CELL SEPARATOR 2997 · Intl. Business Machines510(k) · 1977-09-06
BLOOD CELL PROCESSOR MODEL 2 IBM 2991 · Intl. Business Machines510(k) · 1977-01-10
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.