# K993678: Thrombelastograph Coagulation Analyzer Teg - 5000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Haemoscope Corp.
- Decided: May 5, 2000 after 186 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954137 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954137: QBC Centrifugal Hematology Control, R&D Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K183160: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K993678
Methodology: https://510kreport.com/methodology