# K042795: Clever Chek TD-3213

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Mar 7, 2005 after 151 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: 2 generations back to K021239 (2002). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020208: Glucometer Elite Diabetes Care System (Modified), Bayer Group Diagnostics (2002) Summary page 1.
- K040159: Apm Blood Pressure Monitor, Model BP108A, Asia Pacific Microsystems, Inc. (2004) Summary page 1.

## Most influential descendants
- K062800: Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose Plus Blo (2007), 2 descendants of its own
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (2005), 2 descendants of its own
- K092875: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter (2010), 0 descendants of its own
- K080853: Duo-Care Blood Glucose and Blood Pressure Monitor System (2009), 0 descendants of its own
- K080636: Duo-Max Blood Pressure & Glucose Monitor HMF-100 (2009), 0 descendants of its own

## Indications for use
The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates. The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

Source page: https://510kreport.com/device/K042795
Methodology: https://510kreport.com/methodology