# Ascensia Diabetes Care U.S., Inc.

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 7 (2016–2025): 7 510(k) clearances
- Product codes: NBW (4), QRL (2), QRK (1)
- 510(k) review time since 2016: median 79 days, against 238 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bayer Healthcare, LLC: 3 (https://510kreport.com/company/bayer-healthcare)
- SteriLance Medical (Suzhou), Inc.: 2 (https://510kreport.com/company/sterilance-medical-suzhou)
- Ascensia Diabetes Care: 1 (https://510kreport.com/company/ascensia-diabetes-care)

## Firms that cite its devices most
- Ascensia Diabetes Care: 3 (https://510kreport.com/company/ascensia-diabetes-care)

## Its most-cited devices
- K223293: CONTOUR® NEXT GEN Blood Glucose Monitoring System (2022), cited by 1
- K241787: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (2024), cited by 1
- K162336: Contour Next EZ Blood Glucose Monitoring System (2017), cited by 1
- K160430: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System (2016), cited by 1

## Recent decisions
- K250813: MICROLET®NEXT 2 Lancing Device (May 14, 2025)
- K241787: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (Aug 27, 2024)
- K241810: MICROLET®NEXT Lancet (Aug 15, 2024)
- K223293: CONTOUR® NEXT GEN Blood Glucose Monitoring System (Nov 18, 2022)
- K220633: MICROLET NEXT lancing device, MICROLET Lancet (Jun 3, 2022)
- K162336: Contour Next EZ Blood Glucose Monitoring System (Jan 12, 2017)
- K160430: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System (Jun 24, 2016)

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