510(k) · Cleared
Recalled · Class II · 2016Rotem Delta Thromboelastometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentapharm GmbH · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Mar 23, 2010 as substantially equivalent to K002177 (Haemoscope Corp., 2000) after a 454-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 23, 2010
- Review
- 454 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002177 (2000). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000 · Recalled
- This deviceK083842 Rotem Delta Thromboelastometry SystemPentapharm GmbH · 2010
- Descendant · cites it directly · 4 of its ownK213917 QStat CartridgeHemosonics, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK240045 QStat CartridgeHemosonics, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK230461 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK251404 Quantra QStat CartridgeHemosonics, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK232215 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213917QStat CartridgeHemosonics, LLC · 2022 · cites it directly4descendants
- K240045QStat CartridgeHemosonics, LLC · 2024 · 2 generations on1descendant
- K230461Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · 2 generations on1descendant
- K251404Quantra QStat CartridgeHemosonics, LLC · 2025 · 3 generations on0descendants
- K232215Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | 7 |
| 0 (this device) | K083842 | Rotem Delta Thromboelastometry System | Pentapharm GmbH | 2010 | — |
| +1 | K213917 | QStat Cartridge | Hemosonics, LLC | 2022 | — |
| +2 | K240045 | QStat Cartridge | Hemosonics, LLC | 2024 | — |
| +2 | K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
| +3 | K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025 | — |
| +3 | K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 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 |
|---|---|---|---|
| * | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 SeriesSummary page 1…Studies 3. Identification of the Predicate Thrombelastographo Coagulation Analyzer (TEG®) - 5000 Series K0021 77, Product Code JPA, Haemoscope Corn. 4. Description of the Device The ROTEM® delta Thromboelastometry Syste… | 2000 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2016 | Class II | Z-1090-2016 | Nonconforming Material/Component | Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016. |
| Oct 23, 2014 | Class II | Z-1379-2015 | Nonconforming Material/Component | Some of vials were found to be partially filled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The ROTEM® delta is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation…
Read the full statement (541 words)
The ROTEM® delta is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System.
ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System.
The in-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis.
The hep-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, via the intrinsic pathway in the presence of unfractionated heparin, in citrated whole blood specimens. The hep-TEM® reagent is used to inactivate heparin in patients receiving unfractionated heparin. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis.
The NATEM assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, contact-activated by the surface of the measurement cell, in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis.
The star-TEM® Reagent is intended for use as a recalcification reagent in the NATEM and INTEM assays on the ROTEM® delta Thromboelastometry System.
The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083842: Rotem Delta Thromboelastometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083842
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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