510(k) Report

FDA applicant

Infamed, Ltd.

South West Ranches, FL2 decisions2005–20070 recalls

FDA records 2 decisions for Infamed, Ltd. (South West Ranches, FL) from 2005 to 2007: 2 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). Its devices cite 2 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Infamed, Ltd.’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?

  • CAFNebulizer (Direct Patient Interface)2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K042546Funhaler, Model FH 101Infamed, Ltd. · 20052cite it

What has FDA decided for it lately?

  • K072822Funhaler, Model V-201EInfamed, Ltd. · 2007
  • K042546Funhaler, Model FH 101Infamed, Ltd. · 2005

All 2 as Infamed, Ltd. →