510(k) Report

FDA applicant

Telcare, Inc.

Bethesda, MD1 decision2011–20111 recall

FDA records 1 decision for Telcare, Inc. (Bethesda, MD) in 2011: 1 510(k) clearance. 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. 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 Telcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2011high 1 (2025) · low 0 (2011)2026

Class I Class II/III not classified

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

Planning a device like Telcare, Inc.’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 Counter1decision

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 1 time; 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.

  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use…Telcare, Inc. · 20111cites it

What has FDA decided for it lately?

  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use…Telcare, Inc. · 20111 recall

The one decision as Telcare, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110571Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;Jan 30, 2025Class II