FDA applicant

Amici, Inc.

Spring City, PA8 decisions1987–20070 recalls

FDA records 8 decisions for Amici, Inc. (Spring City, PA) from 1987 to 2007: 8 510(k) clearances. Most are in product codes IYT (System, Rebreathing, Radionuclide) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 2 predicates, 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, radiology panel, where it files most

How often FDA has decided Amici, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Amici, 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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Amici, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?