Product code CHL: 510(k) clearances and predicates
Product code CHL covers ABL90 FLEX PLUS System, safeCLINITUBES. FDA lists 188 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
188 clearances on file under product code CHL. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 so far | 1 |
Recent clearances
Newest CHL clearances in the FDA index, with applicant and decision date:
- K252207, ABL90 FLEX PLUS System, safeCLINITUBES, applicant Radiometer Medicals Aps, decided 2026-04-10. FDA record
- K244014, i-STAT CG4+ cartridge with the i-STAT 1 System, applicant Abbott Point of Care, Inc., decided 2025-05-02. FDA record
- K240998, ABL90 FLEX PLUS System, applicant Radiometer Medicals Aps, decided 2024-12-13. FDA record
- K230285, i-STAT CG8+ cartridge with the i-STAT 1 System, applicant Abbott Point of Care, Inc., decided 2023-10-27. FDA record
- K221900, Stat Profile Prime Plus Analyzer System, applicant Nova Biomedical Corporation, decided 2023-09-29. FDA record
- K223857, i-STAT G3+ cartridge with the i-STAT 1 System, applicant Abbott Point of Care, Inc., decided 2023-09-15. FDA record
- K223608, GEM Premier 7000 with IQM3, applicant Instrumentation Laboratory Company, decided 2023-08-10. FDA record
- K211559, EasyStat 300, applicant Medica Corporation, decided 2023-01-27. 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 i-STAT CG4+ cartridge with the i-STAT 1 System, ABL90 FLEX PLUS System. Watch new CHL 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 CHL?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CHL clearances include ABL90 FLEX PLUS System, safeCLINITUBES.
How many 510(k) clearances use product code CHL?
188 at the time this page was generated, from openFDA records.
How do I find a predicate device under CHL?
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 CHL clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.