# K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color)

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Feb 10, 2009 after 78 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: 2 generations back to K024194 (2003). 2 ancestors in all.
21 later devices descend from it; 12 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB, I-Sens, Inc. (2008) Summary page 1.
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.

## Most influential descendants
- K160742: NoCoding1 Plus Blood Glucose Monitoring System (2016), 5 descendants of its own
- K170614: CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System (2017), 3 descendants of its own
- K103278: Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution (2011), 2 descendants of its own
- K131419: Acura Plus Multi Blood Glucose Monitoring System (2013), 1 descendant of its own
- K121133: Caresens N Voice Blood Glucose Monitoring System (2012), 1 descendant of its own

## Indications for use
The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for self- testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

Source page: https://510kreport.com/device/K083468
Methodology: https://510kreport.com/methodology