# K132862: Healthpro Professional Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Dec 12, 2013 after 91 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: 5 generations back to K942455 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113192: Healthpro Blood Glucose Monitoring System, Infopia Co, Ltd. (2012) Summary page 1.

## Indications for use
The Healthpro Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Healthpro Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Healthpro Professional 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 Professional test strips are for use with the Healthpro Professional 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 Professional Control Solutions are for use with the Healthpro Professional meter and Healthpro Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K132862
Methodology: https://510kreport.com/methodology