FDA applicant

Alcyone Lifesciences, Inc.

Lowell, MA2 decisions2015–20170 recalls

FDA records 2 decisions for Alcyone Lifesciences, Inc. (Lowell, MA) from 2015 to 2017: 2 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and HCD (Cannula, Ventricular). Its devices cite 2 predicates, 0 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, neurology panel, where it files most

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

FDA decisions per year

1in 2017

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Alcyone Lifesciences, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Alcyone Lifesciences, 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?