FDA applicant

Helios Biomedical, Inc.

Weston, MA2 decisions2025–20250 recalls

FDA records 2 decisions for Helios Biomedical, Inc. (Weston, MA) in 2025: 2 510(k) clearances. Most are in product codes GXQ (Dura Substitute) and KGN (Wound Dressing With Animal-Derived Material (S)). 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 Helios Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Helios Biomedical, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Helios”

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

Helios Cardio, Inc. 1

Helios Biomedical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Helios”