510(k) Report

FDA applicant

Maxi-Aids, Inc.

Farmingdale, NY2 decisions1996–20040 recalls

FDA records 2 decisions for Maxi-Aids, Inc. (Farmingdale, NY) from 1996 to 2004: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and EPF (Hearing Aid, Group And Auditory Trainer). 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, cardiovascular panel, where it files most

How often FDA has decided Maxi-Aids, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maxi-Aids, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Maxi-Aids, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • EPFHearing Aid, Group And Auditory Trainer1decision

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.

  • K041778Reizen Talking Blood Pressure Monitor, Model #SF860TMaxi-Aids, Inc. · 20041cites it

What has FDA decided for it lately?

  • K041778Reizen Talking Blood Pressure Monitor, Model #SF860TMaxi-Aids, Inc. · 2004
  • K960567HF Mega EarMaxi-Aids, Inc. · 1996

All 2 as Maxi-Aids, Inc. →