# K110948: Health Care System Software

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: May 13, 2011 after 39 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: 2 generations back to K001907 (2000). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070941: Clever Chek Health Care System Software, Version 1.0, Taidoc Technology Corporation (2007) Summary page 1.

## Most influential descendants
- K113264: Electro Sensor Complex Software (ES Complex Software) (2012), 2 descendants of its own
- K140412: ANS1 Software (2014), 0 descendants of its own
- K130056: Patient Monitor (2013), 0 descendants of its own

## Indications for use
The Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Health Care System Software transfers data from the device's memory into a computer for enhanced data management. The Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

Source page: https://510kreport.com/device/K110948
Methodology: https://510kreport.com/methodology