# K040603: Paradigm Link Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 19, 2004 after 75 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: 1 generation back to K030531 (2003). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030531: Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter, Minimed, Inc. (2003) Summary page 1.
- (no number) BD Logic Blood Glucose Monitor: named in the summary without a submission number
- (no number) Medtronic MiniMed ComLink: named in the summary without a submission number

## Most influential descendants
- K073231: Onetouch Ultralink Blood Glucose Monitoring System (2008), 15 descendants of its own
- K110894: Contour Next Link Wireless Blood Glucose Meter (2012), 13 descendants of its own
- K121087: Contour Next Usb Blood Glucose Monitoring System (2012), 10 descendants of its own
- K150942: Contour Next USB Blood Glucose Monitoring System (2015), 9 descendants of its own
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System (2016), 8 descendants of its own

## Indications for use
The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

Source page: https://510kreport.com/device/K040603
Methodology: https://510kreport.com/methodology