# Ascensia Diabetes Care

- Location (FDA's records): Valhalla, NY
- FDA decisions: 6 (2016–2026): 6 510(k) clearances
- Product codes: NBW (6)
- 510(k) review time since 2016: median 221 days, against 238 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ascensia Diabetes Care U.S., Inc.: 3 (https://510kreport.com/company/ascensia-diabetes-care-us)
- Bayer Healthcare, LLC: 2 (https://510kreport.com/company/bayer-healthcare)

## Firms that cite its devices most
- Ascensia Diabetes Care U.S., Inc.: 1 (https://510kreport.com/company/ascensia-diabetes-care-us)
- Sinocare, Inc.: 1 (https://510kreport.com/company/sinocare)

## Its most-cited devices
- K193407: Contour® next GEN Blood Glucose Monitoring System (2021), cited by 3
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System (2016), cited by 2
- K191286: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System (2019), cited by 1

## Recent decisions
- K260545: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System;  CONTOUR® NEXT ONE Blood Glucose Monitoring System (Aug 27, 2026)
- K231679: CONTOUR® PLUS BLUE Blood Glucose Monitoring System (Feb 23, 2024)
- K193407: Contour® next GEN Blood Glucose Monitoring System (Dec 23, 2021)
- K210687: CONTOUR® NEXT ONE Blood Glucose Monitoring System (Aug 11, 2021)
- K191286: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System (Nov 8, 2019)
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System (Nov 17, 2016)

Source page: https://510kreport.com/company/ascensia-diabetes-care