FDA product code GKZ: Counter, Differential Cell
GKZ is the FDA product code for counter, differential cell. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel. FDA has cleared 381 510(k) submissions under GKZ, 18 in the last five years, from 90 different applicants. The average 510(k) review took 173 days (median 106); 200 days on average over the last three years. FDA has posted 244 recalls for GKZ devices, 22 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Counter, Differential Cell |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for GKZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 269 |
| 2018 | 3 | 248 |
| 2019 | 5 | 196 |
| 2020 | 1 | 156 |
| 2022 | 3 | 563 |
| 2023 | 4 | 366 |
| 2024 | 3 | 153 |
| 2025 | 4 | 157 |
| 2026 | 4 | 290 |
Compare with all 510(k) review times · Search every GKZ clearance
Top GKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 25 | 2024-07-05 |
| Abbott Laboratories | 24 | 2025-02-20 |
| Coulter Corp. | 23 | 2000-04-20 |
| Sysmex America, Inc. | 22 | 2026-05-27 |
| Becton Dickinson Immunocytometry Systems | 21 | 2004-09-10 |
85 more applicants have GKZ clearances. See the full list in Caduvo.
Most recent GKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260781 | HORIBA ABX SAS | Yumizen H550 | 2026-09-14 | 188 |
| K253212 | Sysmex America, Inc. | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | 2026-05-27 | 240 |
| K243348 | Athelas, Inc. | Athelas Home | 2026-02-06 | 466 |
| K251249 | Truvian Sciences, Inc. | Tru Hematology Test | 2026-01-16 | 268 |
| K250943 | Sysmex America, Inc. | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | 2025-06-25 | 89 |
Recalls for GKZ devices
244 product recalls in 139 recall events; 22 initiated in the last five years and 42 still open. Most recent: 2025-09-18.
| Year | Recalls |
|---|---|
| 2017 | 11 |
| 2018 | 5 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 21 |
| 2022 | 5 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 14 |
Frequently asked questions
What is FDA product code GKZ?
GKZ is the FDA product code for counter, differential cell. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel.
What device class is GKZ?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKZ?
Across 381 cleared submissions the average was 173 days from receipt to decision (median 106).
Which companies have the most GKZ clearances?
Beckman Coulter, Inc. (25); Abbott Laboratories (24); Coulter Corp. (23); Sysmex America, Inc. (22); Becton Dickinson Immunocytometry Systems (21).
Have GKZ devices been recalled?
Yes: 244 product recalls across 139 recall events; the most recent began 2025-09-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GKZ
- Run a recall and safety report across every GKZ manufacturer
- Watch product code GKZ 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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