# K193407: Contour® next GEN Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ascensia Diabetes Care
- Decided: Dec 23, 2021 after 745 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K030531 (2003). 10 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System, Ascensia Diabetes Care (2016) Summary page 4.

## Most influential descendants
- K223293: CONTOUR® NEXT GEN Blood Glucose Monitoring System (2022), 2 descendants of its own
- K241787: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (2024), 1 descendant of its own
- K260545: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System;  CONTOUR® NEXT ONE Blood Glucose Monitoring System (2026), 0 descendants of its own
- K231679: CONTOUR® PLUS BLUE Blood Glucose Monitoring System (2024), 0 descendants of its own
- K231476: TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System (2023), 0 descendants of its own

## Recalls of this device
- May 19, 2023 · Class II · Z-2211-2023: Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the Uni

## Indications for use
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next test strips and the Contour® Diabetes app. The Contour® next Gen Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K193407
Methodology: https://510kreport.com/methodology