510(k) Report

FDA applicant

Prodigy Diabetes Care, LLC

Crofton, MD3 decisions2011–20130 recalls

FDA records 3 decisions for Prodigy Diabetes Care, LLC (Crofton, MD) from 2011 to 2013: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 3 predicates, 0 of them its own earlier devices. No 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 Prodigy Diabetes Care, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2011: 12013: 2
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Prodigy Diabetes Care, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prodigy Diabetes Care, LLC’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 Counter3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 20132cite it

What has FDA decided for it lately?

  • K122340Prodigy ChoiceProdigy Diabetes Care, LLC · 2013
  • K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013
  • K103115Prodigy Diabetes Management SoftwareProdigy Diabetes Care, LLC · 2011

All 3 as Prodigy Diabetes Care, LLC →

Other applicant names beginning “Prodigy”

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

Prodigy Technology Consultant Co., Ltd. 1