510(k) Report

FDA applicant

Viratek, Inc.

Costa Mesa, CA5 decisions1985–19903 recalls

FDA records 5 decisions for Viratek, Inc. (Costa Mesa, CA) from 1985 to 1990: 5 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BYL (Tent, Oxygen). 3 recalls are 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 Viratek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Viratek, Inc. since 2007.

Recalls per year

1in 2017

2015: 22017: 1
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Viratek, 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?

  • CAFNebulizer (Direct Patient Interface)2decisions
  • BYLTent, Oxygen2decisions

What has FDA decided for it lately?

  • K896608Spag PakViratek, Inc. · 1990
  • K882396Aerosol Delivery HoodViratek, Inc. · 1988
  • K870051Spag-2 Aerosol Generator W/Use of VirazoleViratek, Inc. · 19872 recalls
  • K871427(Spag) Model Spag-2 6000 SeriesViratek, Inc. · 19873 recalls
  • K843717Viratek Small Particle Aerosol GeneratViratek, Inc. · 1985

All 5 as Viratek, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K871427Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical…Mar 13, 2017Class II
  • K870051Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2…Sep 21, 2015Class II
  • K870051Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol…Sep 14, 2015Class II