# K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB

- Pathway: 510(k) (Traditional)
- Applicant: I-Sens, Inc.
- Decided: Oct 17, 2008 after 198 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: 1 generation back to K024194 (2003). 1 ancestor in all.
22 later devices descend from it; 2 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)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 3.

## Most influential descendants
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color) (2009), 21 descendants of its own
- 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

## Indications for use
The CareSens II, CareSens POP Meters are 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 Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf) CareSens Test Strips work with the CareSens 11, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf) CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.

Source page: https://510kreport.com/device/K080923
Methodology: https://510kreport.com/methodology