510(k) Report

FDA applicant

American Immuno Tech

Costa Mesa, CA1 decision1999–19992 recalls

FDA records 1 decision for American Immuno Tech (Costa Mesa, CA) in 1999: 1 510(k) clearance. All are in product code FYD (Apparatus, Exhaust, Surgical). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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, general and plastic surgery panel, where it files most

How often FDA has decided American Immuno Tech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Immuno Tech since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Immuno Tech 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?

  • FYDApparatus, Exhaust, Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K990037Neptune Waste Management SystemAmerican Immuno Tech · 19991cites it

What has FDA decided for it lately?

  • K990037Neptune Waste Management SystemAmerican Immuno Tech · 19992 recalls

The one decision as American Immuno Tech →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K990037Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model…Oct 12, 2004
  • K990037Stryker brand Neptune waste management system; model 711-27-1.Dec 3, 2002