# K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Haemoscope Corp.
- Decided: Sep 14, 2000 after 57 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System (2011), 6 descendants of its own
- K083842: Rotem Delta Thromboelastometry System (2010), 6 descendants of its own
- K213917: QStat Cartridge (2022), 4 descendants of its own
- K150041: CORA (Coagulation Resonance Analysis) System (2015), 4 descendants of its own
- K243858: TEG 6s Hemostasis System Citrated: K, KH, RT,  FF Assay Cartridge (2025), 1 descendant of its own

## Recalls of this device
- Apr 26, 2022 · Class II · Z-1310-2022: Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal 
- Apr 19, 2022 · Class II · Z-1298-2022: When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition 
- Feb 19, 2020 · Class II · Z-1617-2020: Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result
- Jan 26, 2015 · Class II · Z-1130-2015: Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
- Jun 20, 2013 · Class II · Z-1796-2013: Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
- Mar 4, 2011 · Not classified · Z-2742-2011: Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
- Jan 28, 2011 · Not classified · Z-1738-2011: Haemonetics has received a report of smoke from the unit with a power supply failure.

Source page: https://510kreport.com/device/K002177
Methodology: https://510kreport.com/methodology