510(k) · Cleared
ClearedQuantra QStat Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemosonics, LLC · QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Cleared on Aug 25, 2025 as substantially equivalent to K240045 (Hemosonics, LLC, 2024) after a 111-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Aug 25, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- QFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002177 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000 · Recalled
- 3 generations backK083842 Rotem Delta Thromboelastometry SystemPentapharm GmbH · 2010 · Recalled
- 2 generations backK213917 QStat CartridgeHemosonics, LLC · 2022
- 1 generation backK240045 QStat CartridgeHemosonics, LLC · 2024
- This deviceK251404 Quantra QStat CartridgeHemosonics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | 7 |
| −3 | K083842 | Rotem Delta Thromboelastometry System | Pentapharm GmbH | 2010 | 2 |
| −2 | K213917 | QStat Cartridge | Hemosonics, LLC | 2022 | — |
| −1 | K240045 | QStat Cartridge | Hemosonics, LLC | 2024 | — |
| 0 (this device) | K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFR device
- #1 K213917 QStat Cartridgescore 10.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240045 | QStat CartridgeSummary page 7…pdate). DEVICE MODIFICATION DESCRIPTION The QStat Cartridge was initially cleared under K213917 for liver transplantation and trauma patients. An additional submission (K240045) added a sample matrix claim of arterial whole blood. This 510(k) adds the peripartum obstetric patient as an additional patient… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All QFR devicesQFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFR
Too few QFR 510(k)s in any year since 2007 to give a median.
Recalls per year · QFR
No recall names QFR since 2007.
Adverse event reports per year · QFR
No MAUDE report names QFR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is intended for in vitro…
Read the full statement (173 words)
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The QStat Cartridge is intended for in vitro diagnostic use by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL).
The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma, liver transplantation, and peripartum obstetric procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251404: Quantra QStat Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251404
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026