510(k) Report

FDA applicant

Alr Technologies

Bonita Springs, FL2 decisions2011–20170 recalls

FDA records 2 decisions for Alr Technologies (Bonita Springs, FL) from 2011 to 2017: 2 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and NDC (Calculator, Drug Dose). Its devices cite 5 predicates, 1 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 Alr Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 12017: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Alr Technologies by year, 2011–2026Sources: 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 Counter1decision
  • NDCCalculator, Drug Dose1decision

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K102063Health-E-Connect SystemAlr Technologies · 20111cites it

What has FDA decided for it lately?

  • K163664Health-e-Connect System with IDAAlr Technologies · 2017
  • K102063Health-E-Connect SystemAlr Technologies · 2011

All 2 as Alr Technologies →