# K955278: Behring Coagulation Timer

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: May 30, 1996 after 195 days
- Product code: GGN (Plasma, Coagulation Control)
- 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 K926551 (1995). 1 ancestor in all.
10 later devices descend from it; 7 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926551: Behring Fibrintimer a, Behring Diagnostics, Inc. (1995) Summary page 2.

## Most influential descendants
- K992321: Sysmex Automated Coagulation Analyzer, Model CA-6000 (1999), 4 descendants of its own
- K993174: Sysmex Automated Coagulation Analyzer, Model CA-6000 (1999), 2 descendants of its own
- K970431: Behring Coagulation System (1997), 2 descendants of its own
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant of its own
- K993299: Sysmex Automated Coagulation Analyzer, Model CA-1500 (1999), 1 descendant of its own

## Indications for use
Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coagulation tests.

Source page: https://510kreport.com/device/K955278
Methodology: https://510kreport.com/methodology