Quantra QStat Cartridge
FDA 510(k) clearance K251404 · decided 2025-08-25
Clearance details
- K-number
- K251404
- Device name
- Quantra QStat Cartridge
- Applicant
- Hemosonics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-05-06
- Decision date
- 2025-08-25
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- QFR
- Device class
- 2
- Regulation number
- 864.5430
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QStat Cartridge (K240045) | Hemosonics, LLC | 2024-03-27 |
| Quantra Hemostasis Analyzer (K232215) | Hemosonics, LLC | 2023-08-24 |
| Quantra Hemostasis Analyzer (K230461) | Hemosonics, LLC | 2023-03-24 |
| Quantra QPlus System (K223433) | Hemosonics, LLC | 2022-12-13 |
| QStat Cartridge (K213917) | Hemosonics, LLC | 2022-11-29 |
| Quantra QPlus System (K201513) | Hemosonics, LLC | 2020-08-21 |
| Quantra Hemostasis Analyzer, QPlus Cartridge (DEN180017) | Hemosonics, LLC | 2019-03-12 |
Recalls involving this device
No recalls on record reference this clearance.