510(k) Report

FDA applicant

Aeiomed, Inc.

Stoughton, WI4 decisions2004–20100 recalls

FDA records 4 decisions for Aeiomed, Inc. (Stoughton, WI) from 2004 to 2010: 4 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 9 predicates, 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aeiomed, 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?

  • BZDVentilator, Non-Continuous (Respirator)4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K100121Model 300157 Cpap SystemAeiomed, Inc. · 20104cite it
  • K042130Aura Cpap Patient InterfaceAeiomed, Inc. · 20042cite it
  • K042945Aura Cpap SystemAeiomed, Inc. · 20051cites it
  • K072993Reusable Headrest with Nasal SealAeiomed, Inc. · 20081cites it

What has FDA decided for it lately?

  • K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010
  • K072993Reusable Headrest with Nasal SealAeiomed, Inc. · 2008
  • K042945Aura Cpap SystemAeiomed, Inc. · 2005
  • K042130Aura Cpap Patient InterfaceAeiomed, Inc. · 2004

All 4 as Aeiomed, Inc. →