# K141862: HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable

- Pathway: 510(k) (Traditional)
- Applicant: H2, Inc.
- Decided: Dec 2, 2014 after 145 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: 5 generations back to K861844 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130886: Glooko Device System for Glooko Logbook+ Application, Glooko, Inc. (2013) Summary page 7.

## Indications for use
Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform. Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.

Source page: https://510kreport.com/device/K141862
Methodology: https://510kreport.com/methodology