# K123136: Genesis Health Record System, (GHRS)

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Health Technologies
- Decided: Mar 7, 2013 after 153 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: 4 generations back to K952279 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100937: PC Care Blood Glucose Data Management Software, I-Sens, Inc. (2010) Summary page 1.

## Indications for use
The Genesis Health Record System is an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123 to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not intended to provide automated treatment guidance or decisions. The System is not indicated for the diagnosis or screening of diabetes.

Source page: https://510kreport.com/device/K123136
Methodology: https://510kreport.com/methodology