FDA product code GKT: Separator, Automated, Blood Cell, Diagnostic
GKT is the FDA product code for separator, automated, blood cell, diagnostic. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel. FDA has cleared 10 510(k) submissions under GKT, from 8 different applicants. The average 510(k) review took 96 days (median 84). FDA has posted 1 recall for GKT devices.
Classification
| Field | Value |
|---|---|
| Device name | Separator, Automated, Blood Cell, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 864.9245 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for GKT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 193 |
Compare with all 510(k) review times · Search every GKT clearance
Top GKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Travenol Laboratories, S.A. | 2 | 1980-10-31 |
| Intl. Business Machines | 2 | 1977-09-06 |
| Fresenius Kabi AG | 1 | 2020-09-11 |
| Fresenius Kabi USA,Llc | 1 | 2016-11-23 |
| Cryosan, Inc. | 1 | 1982-09-30 |
3 more applicants have GKT clearances. See the full list in Caduvo.
Most recent GKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200530 | Fresenius Kabi AG | AMICUS Separator System | 2020-09-11 | 193 |
| K162462 | Fresenius Kabi USA,Llc | AMICUS Separator System, AMICUS Separator System; Refurbished | 2016-11-23 | 82 |
| K822521 | Cryosan, Inc. | AUTOMATED BLOOD CELL SEPARATOR | 1982-09-30 | 38 |
| K820396 | Pheragen Technology Corp. | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR | 1982-04-27 | 75 |
| K801233 | Travenol Laboratories, S.A. | CELLTRIFUGE II | 1980-10-31 | 157 |
Recalls for GKT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-25.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code GKT?
GKT is the FDA product code for separator, automated, blood cell, diagnostic. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel.
What device class is GKT?
Class II, regulation 21 CFR 864.9245. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKT?
Across 10 cleared submissions the average was 96 days from receipt to decision (median 84).
Which companies have the most GKT clearances?
Travenol Laboratories, S.A. (2); Intl. Business Machines (2); Fresenius Kabi AG (1); Fresenius Kabi USA,Llc (1); Cryosan, Inc. (1).
Have GKT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GKT
- Run a recall and safety report across every GKT manufacturer
- Watch product code GKT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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