510(k) Report

FDA applicant

Airpharma, LLC

Ramona, CA2 decisions1994–19970 recalls

FDA records 2 decisions for Airpharma, LLC (Ramona, CA) from 1994 to 1997: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)). 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 Airpharma, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Airpharma, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Airpharma, LLC 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?

  • CAFNebulizer (Direct Patient Interface)1decision
  • CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1decision

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.

  • K933090EZ-SpacerAirpharma, LLC · 19941cites it

What has FDA decided for it lately?

  • K964956E-Z Spacer Mask (Small)Airpharma, LLC · 1997
  • K933090EZ-SpacerAirpharma, LLC · 1994

All 2 as Airpharma, LLC →