# K110894: Contour Next Link Wireless Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare
- Decided: Mar 28, 2012 after 364 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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 K030531 (2003). 6 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091820: Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System, Bayer Healthcare (2009) Summary page 1.
- K073231: Onetouch Ultralink Blood Glucose Monitoring System, Lifescan, Inc. (2008) Summary page 1.
- K070438: Medtronic Minimed Carelink Usb Connector, Model NMT 7305, Medtronic Minimed, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K193407: Contour® next GEN Blood Glucose Monitoring System (2021), 5 descendants of its own
- K122370: Contour Next Link Wireless Blood Glucose Monitor (2013), 3 descendants of its own

## Indications for use
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a Contour NEXT LINK Wireless Blood Glucose Meter, CONTOUR® NEXT Test Strips and CONTOUR® NEXT Control Solutions. CONTOUR® NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Source page: https://510kreport.com/device/K110894
Methodology: https://510kreport.com/methodology