# K150041: CORA (Coagulation Resonance Analysis) System

- Pathway: 510(k) (Traditional)
- Applicant: Coramed Technologies, LLC
- Decided: Jun 26, 2015 after 168 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 K002177 (2000). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series, Haemoscope Corp. (2000) Summary page 6.

## Most influential descendants
- K243858: TEG 6s Hemostasis System Citrated: K, KH, RT,  FF Assay Cartridge (2025), 1 descendant of its own
- K251024: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (2025), 0 descendants of its own
- K232018: Citrated: K, KH, RTH, FFH (2024), 0 descendants of its own
- K160502: TEG 6s Hemostasis System (2017), 0 descendants of its own

## Indications for use
The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The CORA System records the kinetic changes in a 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 CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA 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 CORA 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.

Source page: https://510kreport.com/device/K150041
Methodology: https://510kreport.com/methodology