510(k) · Cleared
ClearedROTEM sigma 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 Jul 8, 2022 as substantially equivalent to K083842 (Pentapharm GmbH, 2010) and 1 other predicate after a 767-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 8, 2022
- Review
- 767 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002177 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K201440 | ROTEM sigma Thromboelastometry System | Tem Innovations GmbH | 2022 | — |
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 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? (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 4…Product Code: JPA Classification Panel: Hematology (81) Predicate Device: K083842: ROTEM delta Thromboelastometry System K101533: EX-TEM, FIB-TEM, and AP-TEM for ROTEM delta… | 2010 |
| * | K101533 | EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemSummary page 4…Classification Panel: Hematology (81) Predicate Device: K083842: ROTEM delta Thromboelastometry System K101533: EX-TEM, FIB-TEM, and AP-TEM for ROTEM delta Thromboelastometry System Device Informati… | 2011 |
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 22 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K083842.
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. 2022, 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 sigma thromboelastometry system is a fully integrated and automated in vitro diagnostic system designed to monitor and analyze a patient's coagulation status by measuring the viscoelastic properties of a 3.2% citrated venous or arterial whole blood sample. The ROTEM sigma system is indicated for use with adult patients 21 years and older where a semi-quantitative evaluation of their blood coagulation properties is desired, in the point of care…
Read the full statement (247 words)
The ROTEM sigma thromboelastometry system is a fully integrated and automated in vitro diagnostic system designed to
monitor and analyze a patient's coagulation status by measuring the viscoelastic properties of a 3.2% citrated venous or
arterial whole blood sample. The ROTEM sigma system is indicated for use with adult patients 21 years and older where a
semi-quantitative evaluation of their blood coagulation properties is desired, in the point of care and laboratory settings.
Coagulation evaluations on the ROTEM sigma instrument, together with the ROTEM sigma complete + hep cartridge, are
used to assess peri-operative hemorrhage and/or thrombosis in cardiovascular surgery and liver transplantation.
The single use, multichannel cartridge ROTEM sigma complete + hep contains the following assays:
INTEM C is a semi-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood
samples.
EXTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood
samples.
FIBTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood
samples, after blocking platelet contribution to clot firmness.
HEPTEM C is a sem i-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood
samples, after inactivating heparin.
Results from the ROTEM sigma should not be the sole basis for a patient diagnosis; ROTEM sigma results should be
considered along with a clinical assessment of the patient's condition and other laboratory tests.
For in vitro Diagnostic Use.
For professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201440 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201440: ROTEM sigma 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/K201440
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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