Product code CCK: 510(k) clearances and predicates
Product code CCK covers GF-310R Multigas Unit (GF-310R). FDA lists 307 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
307 clearances on file under product code CCK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 so far | 3 |
Recent clearances
Newest CCK clearances in the FDA index, with applicant and decision date:
- K251641, GF-310R Multigas Unit (GF-310R), applicant Nihon Kohden Corporation, decided 2026-08-12. FDA record
- K261633, VisuBreath, applicant Affirm Medical Technologies II, LLC, decided 2026-07-14. FDA record
- K253030, Capnostream35 Portable Respiratory Monitor (PM35MN), applicant Covidien, LLC, decided 2026-05-01. FDA record
- K250148, Medical Gas Analyzer (AG200), applicant Prior Care Science Technology, Ltd., decided 2025-08-28. FDA record
- K243956, TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1), applicant Nihon Kohden Corporation, decided 2025-06-10. FDA record
- K251216, 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line, applicant Barbaras Development, Inc., decided 2025-06-04. FDA record
- K240937, AIM (N/A), applicant Inventeur, LLC, decided 2024-12-16. FDA record
- K230915, AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask, applicant Vyaire Medical, Inc., decided 2024-11-12. 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 VisuBreath, Capnostream35 Portable Respiratory Monitor (PM35MN). Watch new CCK 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 CCK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CCK clearances include GF-310R Multigas Unit (GF-310R).
How many 510(k) clearances use product code CCK?
307 at the time this page was generated, from openFDA records.
How do I find a predicate device under CCK?
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 CCK clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.