# K181588: POPS! one Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Nov 30, 2018 after 168 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 K031755 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277, Taidoc Technology Corporation (2010) Summary page 5.

## Indications for use
The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component. The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

Source page: https://510kreport.com/device/K181588
Methodology: https://510kreport.com/methodology