# K962857: Coag-a-Mate MTX

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jan 22, 1997 after 184 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- 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 K813564 (1982). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924453: Multi-Channel Discrete Analyzer (Mda-180), Organon Teknika Corp. (1992) Summary page 1.
- K813564: Coag-a-Mate X2, General Diagnostics (1982) Summary page 1.

## Most influential descendants
- K051030: Coag-a-Mate MTX Iii (2005), 0 descendants of its own
- K033137: Potens + (2003), 0 descendants of its own

## Indications for use
The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.

Source page: https://510kreport.com/device/K962857
Methodology: https://510kreport.com/methodology