# K133346: Smartlog Diabetes Management Software

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Dec 19, 2013 after 50 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PC care Blood Glucose Data Management Software: named in the summary without a submission number

## Indications for use
The SmartLog Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is Intended for use in the home and professional settings to help people with diabetes and their health care professionals in the review, analysis and evaluation of glucose test results fior an effective diabetes management program. The SmartLog Diabetes Management Software allows the user to download Blood glucose readings automatically from die meter to the PC.

Source page: https://510kreport.com/device/K133346
Methodology: https://510kreport.com/methodology