# K070593: Trackrecord  Data Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Home Diagnostics, Inc.
- Decided: May 7, 2007 after 66 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K073699: MCT-Diabetes (2008), 7 descendants of its own
- K110571: Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use (2011), 2 descendants of its own
- K120064: Test, Blood Glucose System (2012), 1 descendant of its own
- K083263: Symcare Diabetes Management Program (2009), 1 descendant of its own
- K131173: FIA Blood Glucose Monitoring System (G2) (2014), 0 descendants of its own

## Indications for use
TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

Source page: https://510kreport.com/device/K070593
Methodology: https://510kreport.com/methodology