510(k) · Cleared
Recalled · Class II · 2022Thrombelastograph Coagulation Analyzer Teg-5000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemoscope Corp. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Sep 14, 2000 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 14, 2000
- Review
- 57 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 7
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000
- Descendant · cites it directly · 6 of its ownK101533 EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH · 2011 · Recalled
- Descendant · cites it directly · 6 of its ownK083842 Rotem Delta Thromboelastometry SystemPentapharm GmbH · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK213917 QStat CartridgeHemosonics, LLC · 2022
- Descendant · cites it directly · 4 of its ownK150041 CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101533EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH · 2011 · cites it directly6descendants
- K083842Rotem Delta Thromboelastometry SystemPentapharm GmbH · 2010 · cites it directly6descendants
- K213917QStat CartridgeHemosonics, LLC · 2022 · 2 generations on4descendants
- K150041CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 2015 · cites it directly4descendants
- K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | — |
| +1 | K101533 | EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System | Tem Innovations GmbH | 2011 | 5 |
| +1 | K083842 | Rotem Delta Thromboelastometry System | Pentapharm GmbH | 2010 | 2 |
| +2 | K213917 | QStat Cartridge | Hemosonics, LLC | 2022 | — |
| +1 | K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | 2015 | — |
| +2 | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 144 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 |
|---|---|---|---|---|
| Apr 26, 2022 | Class II | Z-1310-2022 | Other | Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead… |
| Apr 19, 2022 | Class II | Z-1298-2022 | Software design | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on… |
| Feb 19, 2020 | Class II | Z-1617-2020 | Software design | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest… |
| Jan 26, 2015 | Class II | Z-1130-2015 | Process control | Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter. |
| Jun 20, 2013 | Class II | Z-1796-2013 | Labeling False and Misleading | Research Use Only (RUO) parameters were included in TEG 5000 User Manual. |
| Mar 4, 2011 | Not classified | Z-2742-2011 | Other | Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude). |
| Jan 28, 2011 | Not classified | Z-1738-2011 | Other | Haemonetics has received a report of smoke from the unit with a power supply failure. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101533 (Tem Innovations GmbH, 2011) has gone furthest, with 6 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K002177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002177
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026