# K160502: TEG 6s Hemostasis System

- Pathway: 510(k) (Special)
- Applicant: Haemonetics Corporation
- Decided: Apr 19, 2017 after 421 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: 2 generations back to K002177 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150041: CORA (Coagulation Resonance Analysis) System, Coramed Technologies, LLC (2015) Summary page 4.

## Indications for use
The TEG 6s System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The TEG 6s System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The TEG 6s System provides specific blood modifiers, in the form of reagents dried-in-place within TEG 6s cartridges. 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 use for the TEG 6s System 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.

Source page: https://510kreport.com/device/K160502
Methodology: https://510kreport.com/methodology