Product code GGP: 510(k) clearances and predicates
Product code GGP covers HemosIL von Willebrand Factor Antigen. FDA lists 190 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
190 clearances on file under product code GGP. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 0 |
| 2025 | 1 |
| 2026 so far | 0 |
Recent clearances
Newest GGP clearances in the FDA index, with applicant and decision date:
- K251440, CRYOcheck Chromogenic Factor VIII, applicant Precision Biologic, Inc., decided 2025-08-25. FDA record
- K230852, HemosIL Chromogenic Factor IX, applicant Instrumentation Laboratory Company, decided 2023-12-13. FDA record
- K220728, vWF Ag, applicant Siemens Healthcare Diagnostics Products GmbH, decided 2023-06-02. FDA record
- K214002, CRYOcheck Chromogenic Factor IX, applicant Precision Biologic, Inc., decided 2022-12-23. FDA record
- K223402, HemosIL von Willebrand Factor Antigen, applicant Instrumentation Laboratory CO, decided 2022-12-09. FDA record
- K200033, HemosIL von Willebrand Factor Antigen, applicant Instrumentation Laboratory CO, decided 2020-08-19. FDA record
- K193204, Cryocheck Chromogenic Factor VIII, applicant Precision Biologic, decided 2020-07-17. FDA record
- K183440, CRYOcheck FVIII Inhibitor Kit, applicant Precision Biologic, Inc., decided 2019-03-12. 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 CRYOcheck Chromogenic Factor VIII, HemosIL Chromogenic Factor IX. Watch new GGP 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 GGP?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GGP clearances include HemosIL von Willebrand Factor Antigen.
How many 510(k) clearances use product code GGP?
190 at the time this page was generated, from openFDA records.
How do I find a predicate device under GGP?
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 GGP clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.