# K111029: Fora Poct Managment System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jul 1, 2011 after 79 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K010605 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010605: Atlast Data Management Software (DMS), Amira Medical, Inc. (2001) Summary page 1.

## Indications for use
The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system. The FORA POCT Management System may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional.

Source page: https://510kreport.com/device/K111029
Methodology: https://510kreport.com/methodology