# K930454: Boehringer Mannheim Coaguchek System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 5, 1993 after 190 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K994349: Coaguchek S System, Model 2138280 (2000), 1 descendant of its own
- 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-0099-06: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

Source page: https://510kreport.com/device/K930454
Methodology: https://510kreport.com/methodology