FDA applicant

Helix Opco, LLC

Toronto, CA2 decisions2020–20200 recalls

FDA records 2 decisions for Helix Opco, LLC (Toronto, CA) in 2020: 1 510(k) clearance and 1 De Novo grant. Most are in product codes QNC (Whole Exome Sequencing Constituent Device) and PTA (Genetic Variant Detection And Health Risk…). Its devices cite 1 predicate, 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

How often FDA has decided Helix Opco, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Helix Opco, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Helix Opco, LLC’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 “Helix”

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

Helix Medical, Inc. 18 Helix Diagnostics, Inc. 15

Helix Opco, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Helix”