510(k) Report

FDA applicant

Hoffman Laboratories, LLC

Chatsworth, CA2 decisions2005–20060 recalls

FDA records 2 decisions for Hoffman Laboratories, LLC (Chatsworth, CA) from 2005 to 2006: 2 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 4 predicates, 0 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 Hoffman Laboratories, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hoffman Laboratories, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hoffman Laboratories, 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?

  • BZDVentilator, Non-Continuous (Respirator)2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K052597Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC · 20053cite it

What has FDA decided for it lately?

  • K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC · 2006
  • K052597Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC · 2005

All 2 as Hoffman Laboratories, LLC →