510(k) Report

FDA applicant

Stevenson Industries, Inc.

Simi Valley, CA2 decisions1999–20140 recalls

FDA records 2 decisions for Stevenson Industries, Inc. (Simi Valley, CA) from 1999 to 2014: 2 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 1 predicate, 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 Stevenson Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stevenson Industries, Inc. 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

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.

  • K992384Cpap/Pro Cpap InterfaceStevenson Industries, Inc. · 19993cite it

What has FDA decided for it lately?

  • K141152AdvantageStevenson Industries, Inc. · 2014
  • K992384Cpap/Pro Cpap InterfaceStevenson Industries, Inc. · 1999

All 2 as Stevenson Industries, Inc. →