510(k) · Cleared
Recalled · Class II · 2020TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corporation · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on May 9, 2019 as substantially equivalent to K993678 (Haemoscope Corp., 2000) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- May 9, 2019
- Review
- 175 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954137 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK954137 QBC Centrifugal Hematology ControlR&D Systems, Inc. · 1995
- 1 generation backK993678 Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesHaemoscope Corp. · 2000
- This deviceK183160 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954137 | QBC Centrifugal Hematology Control | R&D Systems, Inc. | 1995 | — |
| −1 | K993678 | Thrombelastograph Coagulation Analyzer Teg - 5000 Series | Haemoscope Corp. | 2000 | — |
| 0 (this device) | K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K993678 | Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesSummary page 5…Studies Regulation Number: 21 CFR 864.5425 Product Code: JPA, GGN Device Class: 2 PREDICATE DEVICE Thrombelastograph® Coagulation Analyzer (TEG®) – 5000, K993678/K002177, Product Code JPA (System, Multipurpose, for In Vitro Coagulation Studies), Haemoscope Corporation DESCRIPTION OF THE DE… | 2000 |
| * | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 SeriesSummary page 5…Regulation Number: 21 CFR 864.5425 Product Code: JPA, GGN Device Class: 2 PREDICATE DEVICE Thrombelastograph® Coagulation Analyzer (TEG®) – 5000, K993678/K002177, Product Code JPA (System, Multipurpose, for In Vitro Coagulation Studies), Haemoscope Corporation DESCRIPTION OF THE DEVICE Sys… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2020 | Class II | Z-2061-2020 | Under Investigation by firm | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2019, 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 TEG® 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and TEG 6s Citrated: K, RT, FF Assay Cartridge. The TEG® 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The TEG® 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots. The Citrated: K, RT, FF Assay Cartridge contains three…
Read the full statement (315 words)
The TEG® 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and TEG 6s Citrated: K, RT, FF Assay Cartridge. The TEG® 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The TEG® 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots.
The Citrated: K, RT, FF Assay Cartridge contains three independent assays (CK, CRT and CFF) and the system output consists of a table of numerical values for parameters R, LY30, and MA.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and LY30 (fibrinolysis after 30 minutes of reaching maximum clot strength).
The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. Clotting characteristics are described by the functional parameter MA (maximum clot strength).
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG® 6s Hemostasis System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameter MA (maximum clot strength).
Results from the TEG® 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. The indication for TEG® 6s Hemostasis System use is with adult patients (18 years and older) where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the TEG® 6s Hemostasis System using the Citrated: K, RT, FF Assay Cartridge is used to assess clinical conditions in a trauma setting to assess hemorrhage or thrombosis conditions.
For professional use only.
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/K183160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183160: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183160
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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