510(k) Report

FDA applicant

Activaero America, Inc.

Bonita Springs, FL3 decisions2007–20090 recalls

FDA records 3 decisions for Activaero America, Inc. (Bonita Springs, FL) from 2007 to 2009: 3 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and NVP (Holding Chambers, Direct Patient Interface). Its devices cite 10 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 Activaero America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Activaero America, 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?

  • CAFNebulizer (Direct Patient Interface)2decisions
  • NVPHolding Chambers, Direct Patient Interface1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K072019AKITA2 ApixnebActivaero America, Inc. · 20073cite it

What has FDA decided for it lately?

  • K090730Akita JetActivaero America, Inc. · 2009
  • K080100WatchhalerActivaero America, Inc. · 2008
  • K072019AKITA2 ApixnebActivaero America, Inc. · 2007

All 3 as Activaero America, Inc. →