# K994349: Coaguchek S System, Model 2138280

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 6, 2000 after 258 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930454 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930454: Boehringer Mannheim Coaguchek System, Boehringer Mannheim Corp. (1993) Summary page 1.

## Most influential descendants
- K071265: Smartcheck Inr System (2007), 0 descendants of its own

## Recalls of this device
- Feb 28, 2007 · Not classified · Z-0737-2007: The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- Oct 18, 2006 · Not classified · Z-0227-2007: Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
- Mar 28, 2005 · Not classified · Z-0100-06: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

## Indications for use
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.

Source page: https://510kreport.com/device/K994349
Methodology: https://510kreport.com/methodology