# K113192: Healthpro Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Jul 13, 2012 after 256 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 K942455 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091157: Gluco Lab Auto Coding, Model Igm-0022, Infopia Co, Ltd. (2009) Summary page 2.

## Most influential descendants
- K132862: Healthpro Professional Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The Healthpro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Healthpro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Healthpro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Healthpro test strips are for use with the Healthpro meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro control solutions are for use with the Healthpro meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K113192
Methodology: https://510kreport.com/methodology