# K101597: Wavesense Diabetes Manager Model Version 1.3.4

- Pathway: 510(k) (Special)
- Applicant: Agamatrix
- Decided: Oct 18, 2010 after 132 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.
11 later devices descend from it; 2 cite it directly.
0 of 15 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 1.

## Most influential descendants
- K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D (2011), 9 descendants of its own
- K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application (2014), 4 descendants of its own
- K150817: Dario Blood Glucose Monitoring System (2015), 2 descendants of its own
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (2016), 1 descendant of its own
- K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application (2013), 1 descendant of its own

## Indications for use
The WaveSense Diabetes Manager (WOM) application (app) is intended for use in the home and professional settings to aid individuals with diabetes and their healthcare professionals; in the review, analysis and evaluation of blood glucose readings to support an effective diabetes managemnent-program. The WaveSense Diabetes Manager application is a digital logbook and. diabetes management tool designed to operate using the iPhone Operating System platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled blood glucose meter (BGM) with a mini-USB poll.

Source page: https://510kreport.com/device/K101597
Methodology: https://510kreport.com/methodology