510(k) Report

FDA applicant

Entra Health Systems

San Diego, CA3 decisions2009–20160 recalls

FDA records 3 decisions for Entra Health Systems (San Diego, CA) from 2009 to 2016: 3 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Entra Health Systems, Ltd.”.

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 Entra Health Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2009: 12014: 12016: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Entra Health Systems by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 20092cite it

What has FDA decided for it lately?

  • K143169MyGlucoHealth Wireless SystemEntra Health Systems · 2016
  • K132930Myhealthpoint Telehealth ManagerEntra Health Systems · 2014
  • K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009

All 2 as Entra Health Systems →The one decision as Entra Health Systems, Ltd. →