GKT
10 FDA 510(k) clearances · Product code
86 daysmedian time to decision
193 days90th percentile
10clearances measured
FDA profile
- Official device name
- Separator, Automated, Blood Cell, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9245
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2021: 490 · 2022: 445 · 2023: 343 · 2024: 444 · 2025: 233 · 2026: 77
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMICUS Separator System (K200530) | Fresenius Kabi AG | 2020-09-11 |
| AMICUS Separator System, AMICUS Separator System; Refurbished (K162462) | Fresenius Kabi USA,Llc | 2016-11-23 |
| AUTOMATED BLOOD CELL SEPARATOR (K822521) | Cryosan, Inc. | 1982-09-30 |
| AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR (K820396) | Pheragen Technology Corp. | 1982-04-27 |
| CELLTRIFUGE II (K801233) | Travenol Laboratories, S.A. | 1980-10-31 |
| STERILE, DISPOSABLE CENTRIFUGE BOWL (K791106) | Travenol Laboratories, S.A. | 1979-08-10 |
| TERUMO IMUGARD (K790105) | Terumo America, Inc. | 1979-05-24 |
| FILTER, EYRPUR DISPOSABLE LEUKOCITE (K781803) | Metrix Teknika, Inc. | 1979-01-17 |
| BLOOD CELL SEPARATOR 2997 (K771258) | Intl. Business Machines | 1977-09-06 |
| BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (K760856) | Intl. Business Machines | 1977-01-10 |
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Every clearance here is in the API, with alerts when new ones post.