# K100322: TD-4277 Blood Glucose Monitoring System, Model 4277

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 28, 2010 after 144 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: 3 generations back to K031755 (2003). 5 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082169: Pro Glucose Test Strip, Taidoc Technology Corporation (2008) Summary page 2.
- K090187: Fora G30 Blood Glucose Monitoring System, Model TD-4241, Taidoc Technology Corporation (2009) Summary page 2.

## Most influential descendants
- K190579: TD-4183 Blood Glucose Monitoring System (2019), 1 descendant of its own
- K222126: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (2024), 0 descendants of its own
- K181588: POPS! one Blood Glucose Monitoring System (2018), 0 descendants of its own
- K173511: ActiveCare TD-4121 Blood Glucose Monitoring System (2018), 0 descendants of its own
- K113768: U-Right TD-4280 Blood Glucose Monitoring System (2012), 0 descendants of its own

## Indications for use
TD-4277 Blood Glucose Monitoring System, Model TD-4277 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.

Source page: https://510kreport.com/device/K100322
Methodology: https://510kreport.com/methodology