Product code GKZ: 510(k) clearances and predicates
Product code GKZ covers Yumizen H550. FDA lists 381 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
381 clearances on file under product code GKZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 so far | 4 |
Recent clearances
Newest GKZ clearances in the FDA index, with applicant and decision date:
- K260781, Yumizen H550, applicant HORIBA ABX SAS, decided 2026-09-14. FDA record
- K253212, XR-Series (XR-10, XR-20) Automated Hematology Analyzers, applicant Sysmex America, Inc., decided 2026-05-27. FDA record
- K243348, Athelas Home, applicant Athelas, Inc., decided 2026-02-06. FDA record
- K251249, Tru Hematology Test, applicant Truvian Sciences, Inc., decided 2026-01-16. FDA record
- K251371, Sysmex XR-Series (XR-20) Automated Hematology Analyzer, applicant Sysmex America, Inc., decided 2025-06-25. FDA record
- K250943, Sysmex XR-Series (XR-10) Automated Hematology Analyzer, applicant Sysmex America, Inc., decided 2025-06-25. FDA record
- K243283, Alinity h-series System, applicant Abbott Laboratories, decided 2025-02-20. FDA record
- K240402, Cito CBC System, applicant Cytochip, Inc., decided 2025-02-03. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include XR-Series (XR-10, XR-20) Automated Hematology Analyzers, Athelas Home. Watch new GKZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code GKZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GKZ clearances include Yumizen H550.
How many 510(k) clearances use product code GKZ?
381 at the time this page was generated, from openFDA records.
How do I find a predicate device under GKZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new GKZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.