Hemosonics, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hemosonics, LLC” (first 2020, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 74 days, against 74 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 74 |
| 2021 | 0 | — |
| 2022 | 2 | 189 |
| 2023 | 2 | 30 |
| 2024 | 1 | 82 |
| 2025 | 1 | 111 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hemosonics, LLC took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 74 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFR | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties | 8 | 7 |
Review panels
- Hematology (8)
Most recent Hemosonics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251404 | Quantra QStat Cartridge | QFR | 2025-08-25 | 111 |
| K240045 | QStat Cartridge | QFR | 2024-03-27 | 82 |
| K232215 | Quantra Hemostasis Analyzer | QFR | 2023-08-24 | 29 |
| K230461 | Quantra Hemostasis Analyzer | QFR | 2023-03-24 | 31 |
| K223433 | Quantra QPlus System | QFR | 2022-12-13 | 29 |
| K213917 | QStat Cartridge | QFR | 2022-11-29 | 349 |
| K201513 | Quantra QPlus System | QFR | 2020-08-21 | 74 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180017 | De Novo | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties | 2019-03-12 |
Recalls
openFDA lists no recalls under a recalling firm named Hemosonics, 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 Hemosonics, LLC is the lead sponsor of 19 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06255496: QStat Cartridge in Obstetric Patients (Completed, started 2024-05-09)
- NCT06415760: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients (Completed, started 2024-05-07)
- NCT06025708: Quantra QStat Sample Type Comparison (Completed, started 2023-09-11)
- NCT05875987: Evaluation of the Quantra QStat System in Obstetric Patients (Completed, started 2023-06-01)
- NCT05426564: Exploratory Assessment of the Quantra® System in Adult ECMO Patients (Completed, started 2022-09-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemosonics, LLC?
FDA lists 7 510(k) clearances under the applicant name “Hemosonics, LLC” (first 2020, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hemosonics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemosonics, LLC is 74 days. Since 2017: 74 days, versus 74 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hemosonics, LLC?
The most frequent FDA product codes under this applicant name are QFR (Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties, 8).
Next steps
- See all 7 Hemosonics, LLC clearances with predicates and recalls
- Run predicate analysis for product code QFR, Hemosonics, 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.