510(k) Report

FDA applicant

Ascensia Diabetes Care

Valhalla, NY6 decisions2016–20261 recall

FDA records 6 decisions for Ascensia Diabetes Care (Valhalla, NY) from 2016 to 2026: 6 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 238 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Ascensia Diabetes Care’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12019: 12021: 22024: 12026 (partial year): 1
2016high 2 (2021) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2016high 1 (2023) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Ascensia Diabetes Care by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ascensia Diabetes Care’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 221 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 238 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 20213cite it
  • K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 20162cite it
  • K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR®…Ascensia Diabetes Care · 20191cites it

What has FDA decided for it lately?

  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2024
  • K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 20211 recall
  • K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021
  • K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR®…Ascensia Diabetes Care · 2019
  • K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016

All 6 as Ascensia Diabetes Care →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193407Contour¿ next GEN Blood Glucose Monitoring SystemMay 19, 2023Class II

Other applicant names beginning “Ascensia”

FDA records each applicant name separately; these may or may not be the same firm.

Ascensia Diabetes Care U.S., Inc. 7