Quantra QPlus System
510(k) K201513
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201513 | Date21 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K201513
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QFR
- FDA applicant
- Hemosonics, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5430
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Quantra QPlus System is a coagulation system for the measurement of whole blood viscoelastic properties. It is classified as a Class II medical device under regulation number 864.5430 and has received FDA 510(k) clearance as substantially equivalent.
The system is supplied by Hemosonics LLC and is intended for use in hematology settings. It requires specific cartridges (QPlus® and QStat®) for operation and is used with the Quantra® Hemostasis Analyzer. Storage, handling, and use should follow the manufacturer's instructions for use as detailed in the device labeling.
Devices cleared under K201513
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Quantra QPlus System KT-0039 | KT-0039 / KT-0039 | 00850003761107 | — | On the market |