510(k) · Cleared
ClearedQStat 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 Nov 29, 2022 as substantially equivalent to K083842 (Pentapharm GmbH, 2010) and 1 other predicate after a 349-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 29, 2022
- Review
- 349 days
- Class
- Class II
- Product code
- QFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002177 (2000). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000 · Recalled
- 1 generation backK083842 Rotem Delta Thromboelastometry SystemPentapharm GmbH · 2010 · Recalled
- This deviceK213917 QStat CartridgeHemosonics, LLC · 2022
- Descendant · cites it directly · 1 of its ownK240045 QStat CartridgeHemosonics, LLC · 2024
- Descendant · cites it directly · 1 of its ownK230461 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK251404 Quantra QStat CartridgeHemosonics, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK232215 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K240045QStat CartridgeHemosonics, LLC · 2024 · cites it directly1descendant
- K230461Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · cites it directly1descendant
- K251404Quantra QStat CartridgeHemosonics, LLC · 2025 · 2 generations on0descendants
- K232215Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | 7 |
| −1 | K083842 | Rotem Delta Thromboelastometry System | Pentapharm GmbH | 2010 | 2 |
| 0 (this device) | K213917 | QStat Cartridge | Hemosonics, LLC | 2022 | — |
| +1 | K240045 | QStat Cartridge | Hemosonics, LLC | 2024 | — |
| +1 | K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
| +2 | K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025 | — |
| +2 | K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 K251404 Quantra QStat Cartridgescore 10.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K083842 | Rotem Delta Thromboelastometry SystemSummary page 8…cleaning. J. SUBSTANTIAL EQUIVALENCE INFORMATION 1. Predicated Device Name: ROTEM Delta Thromboelastometry System 2. Predicate 510(k) Numbers: K083842 and K101533 3. Comparison with Predicate: ROTEM Delta Thromb… | 2010 |
| * | K101533 | EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemSummary page 8…J. SUBSTANTIAL EQUIVALENCE INFORMATION 1. Predicated Device Name: ROTEM Delta Thromboelastometry System 2. Predicate 510(k) Numbers: K083842 and K101533 3. Comparison with Predicate: ROTEM Delta Thromboelastometry… | 2011 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K240045 (Hemosonics, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K083842.
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. 2022, 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 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…
Read the full statement (169 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 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 and liver transplantation procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213917 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213917: QStat Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213917
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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