# K100937: PC Care Blood Glucose Data Management Software

- Pathway: 510(k) (Traditional)
- Applicant: I-Sens, Inc.
- Decided: Dec 21, 2010 after 260 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: 3 generations back to K952279 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062434: Zero-Click Data Management System, Model 8000-01528, Agamatrix (2006) Summary page 3.

## Most influential descendants
- K123136: Genesis Health Record System, (GHRS) (2013), 0 descendants of its own

## Indications for use
The PC care TMBlood Glucose Data Management Software is PC-based software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care Blood Glucose Data Management Software connects to an 1-SENS blood glucose meter, which comes with a PC care USB cable. The PC carem Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically ftom the meter to the PC.

Source page: https://510kreport.com/device/K100937
Methodology: https://510kreport.com/methodology