Product code CGA: 510(k) clearances and predicates
Product code CGA covers ABL90 FLEX PLUS System. FDA lists 401 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
401 clearances on file under product code CGA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 0 |
| 2026 so far | 1 |
Recent clearances
Newest CGA clearances in the FDA index, with applicant and decision date:
- K252488, ABL90 FLEX PLUS System, applicant Radiometer Medicals Aps, decided 2026-05-01. FDA record
- K210933, YSI 2900C Biochemistry Analyzer, applicant Ysi, Inc., decided 2024-09-30. FDA record
- K220328, EasyStat 300, applicant Medica Corporation, decided 2024-07-26. FDA record
- K223179, Cholestech LDX System, applicant Alere San Diego, Inc., decided 2023-09-20. FDA record
- K223755, i-STAT G cartridge with the i-STAT 1 System, applicant Abbott Point of Care, Inc., decided 2023-09-11. FDA record
- K223710, i-STAT CG8+ cartridge with the i-STAT 1 System, applicant Abbott Point of Care, Inc., decided 2023-07-28. FDA record
- K223090, GEM Premier ChemSTAT, applicant Instrumentation Laboratory CO, decided 2023-01-27. FDA record
- K203549, Nova Primary Glucose Analyzer System, applicant Nova Biomedical Corporation, decided 2022-10-18. 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 YSI 2900C Biochemistry Analyzer, EasyStat 300. Watch new CGA 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 CGA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CGA clearances include ABL90 FLEX PLUS System.
How many 510(k) clearances use product code CGA?
401 at the time this page was generated, from openFDA records.
How do I find a predicate device under CGA?
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 CGA clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.