510(k) · Cleared
ClearedThrombelastograph 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 May 5, 2000 as substantially equivalent to K954137 (R&D Systems, Inc., 1995) after a 186-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- May 5, 2000
- Review
- 186 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954137 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954137 QBC Centrifugal Hematology ControlR&D Systems, Inc. · 1995
- This deviceK993678 Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesHaemoscope Corp. · 2000
- Descendant · cites it directly · 0 of its ownK183160 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954137 | QBC Centrifugal Hematology Control | R&D Systems, Inc. | 1995 | — |
| 0 (this device) | K993678 | Thrombelastograph Coagulation Analyzer Teg - 5000 Series | Haemoscope Corp. | 2000 | — |
| +1 | K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K954137 | QBC Centrifugal Hematology ControlSummary page 1…ication Name Multipurpose System for In Vitro Coagulation Studies Identification of ThrombelastographE Coagulation Analyzer — 3000S, Equivalent Devices Haemoscope Corp. (K954137) Device Description The TEG - 5000 Series Analyzer consists of a two-column TEG instrument, a computer interface module, softwa… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | 2019 | 0 |
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?
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 | — |
What is it indicated for?
The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations are commonly used to assess clinical conditions such as post-operative hemorrhage and / or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.
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/K993678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993678: Thrombelastograph Coagulation Analyzer Teg - 5000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993678
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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