510(k) · Cleared
ClearedQuantra Hemostasis Analyzer
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 24, 2023 as substantially equivalent to K230461 (Hemosonics, LLC, 2023) after a 29-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Aug 24, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- QFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002177 (2000). 7 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 backK230461 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
- This deviceK232215 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
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 | K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
| 0 (this device) | K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K230461 | Quantra Hemostasis AnalyzerSummary page 4…K232215 Quantra® Hemostasis Analyzer and QPlus Cartridge Special 510(k) Device Modification to K230461 510(K) SUMMARY A. APPLICANT INFORMATION Submission Date: July 26, 2023 Submitter Information:… | 2023 |
| † | DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | 2019 |
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 23 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 7 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. 2023, 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 Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, QStat Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra System is intended for in vitro diagnostic use. The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The system is intended to be used by trained…
Read the full statement (260 words)
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, QStat Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood.
The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. The QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
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. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
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/K232215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232215: Quantra Hemostasis Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232215
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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