FDA applicant

Hyperion, Inc.

Miami, FL8 decisions1984–20020 recalls

FDA records 8 decisions for Hyperion, Inc. (Miami, FL) from 1984 to 2002: 8 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and DHN (Antinuclear Antibody, Indirect…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Hyperion, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hyperion, 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?