Hepquant, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Hepquant, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SIO | Test For Esophageal Varices | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220016 | PMA | HepQuant SHUNT® Liver Diagnostic Test | 2026-06-18 |
Recalls
openFDA lists no recalls under a recalling firm named Hepquant, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Hepquant, LLC is the lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07009132: Cholate Clearance in Fontan and Heart Failure (Recruiting, started 2025-08-04)
- NCT07060547: Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease (Recruiting, started 2025-06-10)
- NCT01579162: Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation (Completed, started 2012-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hepquant, LLC?
FDA lists 0 510(k) clearances under the applicant name “Hepquant, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Hepquant, LLC?
The most frequent FDA product codes under this applicant name are SIO (Test For Esophageal Varices, 1).
Next steps
- See all 0 Hepquant, LLC clearances with predicates and recalls
- Run predicate analysis for product code SIO, Hepquant, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.