Product code CHH: 510(k) clearances and predicates
Product code CHH covers Lipids. FDA lists 230 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
230 clearances on file under product code CHH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 0 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 so far | 0 |
Recent clearances
Newest CHH clearances in the FDA index, with applicant and decision date:
- K251091, Lipids, applicant Truvian Health, decided 2025-12-30. FDA record
- K232404, CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES, applicant Medicon Hellas S.A, decided 2024-08-09. FDA record
- K203597, Cholesterol2, applicant Abbott Ireland Diagnostics Division, decided 2022-06-30. FDA record
- K190490, VITROS XT Chemistry Products TRIG-CHOL Slides, applicant Ortho-Clinical Diagnostics, Inc., decided 2019-03-27. FDA record
- K181373, Extended Lipid Panel Assay, applicant Laboratory Corporation of America Holdings, decided 2018-10-18. FDA record
- K180504, Mission Lipid Panel Monitoring System, applicant ACON Laboratories, Inc., decided 2018-03-28. FDA record
- K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System, applicant ACON Laboratories, Inc., decided 2017-07-11. FDA record
- K151545, CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System, applicant Polymer Technology Systems, Inc., decided 2016-12-22. 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 CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES, Cholesterol2. Watch new CHH 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 CHH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CHH clearances include Lipids.
How many 510(k) clearances use product code CHH?
230 at the time this page was generated, from openFDA records.
How do I find a predicate device under CHH?
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 CHH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.