510(k) Report

FDA applicant

Aeolus International Corporation

Marion, MA1 decision2002–20020 recalls

FDA records 1 decision for Aeolus International Corporation (Marion, MA) in 2002: 1 510(k) clearance. All are in product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). 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, dental panel, where it files most

How often FDA has decided Aeolus International Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aeolus International Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aeolus International Corporation 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?

  • MYBPillow, Cervical (For Mild Sleep Apnea)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K023010Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 20022cite it

What has FDA decided for it lately?

  • K023010Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002

The one decision as Aeolus International Corporation →