510(k) · Cleared
Recalled · Class II · 2019EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tem Innovations GmbH · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Aug 10, 2011 as substantially equivalent to K002177 (Haemoscope Corp., 2000) after a 433-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 10, 2011
- Review
- 433 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 5
- 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 deviceK101533 EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH · 2011
- 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) | K101533 | EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System | Tem Innovations GmbH | 2011 | — |
| +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 4.3 Identification of the predicate Thrombelastograph® Coagulation Analyzer (TEG®) - 5000 Series K002177, Product Code JPA, Haemoscope Corp. 4.4 Description of the Device The three assays are system reagents… | 2000 |
| † | K083842 | Rotem Delta Thromboelastometry System | 2010 |
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 |
|---|---|---|---|---|
| Jul 23, 2019 | Class II | Z-2485-2019 | Nonconforming Material/Component | Prolonged clotting times |
| Jul 23, 2019 | Class II | Z-2487-2019 | Nonconforming Material/Component | Prolonged clotting times |
| Jul 23, 2019 | Class II | Z-2486-2019 | Nonconforming Material/Component | Prolonged clotting times |
| Sep 13, 2016 | Class II | Z-0302-2017 | Nonconforming Material/Component | Customers complained of low/empty reagent vials. |
| 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. 2011, 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 EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM8 delta Thromboelastometry System to monitor the coagulation process via the extrinsic 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)). Speed of clot formation time (OFT and alpha) is…
Read the full statement (397 words)
The EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM8 delta Thromboelastometry System to monitor the coagulation process via the extrinsic 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)). Speed of clot formation time (OFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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 FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness The fib-TEM® reagent is always used in conjunction with ex-TEM® reagent.
Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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 APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM®D delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. The ap-TEM® reagent is always used in conjunction with ex-TEM® reagent.
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)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101533 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101533
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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