FDA applicant

Heyer America, Inc.

Washington, DC4 decisions1991–20011 recall

FDA records 4 decisions for Heyer America, Inc. (Washington, DC) from 1991 to 2001: 4 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Heyer America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heyer America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Heyer America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heyer America, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Heyer”

FDA records each applicant name separately; these may or may not be the same firm.

Heyer Schulte Corp. 9

Heyer America, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Heyer”