510(k) · Cleared
ClearedTEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Apr 30, 2025 as substantially equivalent to K243858 (Haemonetics Corporation, 2025) after a 28-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 30, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002177 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002177 Thrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. · 2000 · Recalled
- 2 generations backK150041 CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC · 2015
- 1 generation backK243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation · 2025
- This deviceK251024 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002177 | Thrombelastograph Coagulation Analyzer Teg-5000 Series | Haemoscope Corp. | 2000 | 7 |
| −2 | K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | 2015 | — |
| −1 | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | 2025 | — |
| 0 (this device) | K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | 2025 | — |
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 |
|---|---|---|---|
| * | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeSummary page 6…864.5425 Product Code: JPA II. Legally Marketed Predicate Device Predicate # Predicate Trade Name Product Code K243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay JPA Cartridge III. Device Description… | 2025 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.6 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. 2025, 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 is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a 3.2% citrated whole blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s…
Read the full statement (341 words)
The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a 3.2% citrated whole blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).
The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests.
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 System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).
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 System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251024 · printed Nov 3, 2026
Cite this page
510(k) Report. “K251024: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K251024
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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