# K091820: Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare
- Decided: Aug 26, 2009 after 69 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
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K193407: Contour® next GEN Blood Glucose Monitoring System (2021), 5 descendants of its own

## Indications for use
The Contour USB Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Contour USB is an over the counter (OTC) device utilized by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Contour USB Diabetes Care System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from fingertip, palm and forearm. The Contour USB is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. GLUCOFACTS® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by Health Care Professionals and Patients with Diabetes for viewing and printing reports that display blood sugar readings from Bayer's CONTOUR® and BREEZE® families of meters.

Source page: https://510kreport.com/device/K091820
Methodology: https://510kreport.com/methodology