510(k) Report

FDA applicant

Omnyx, LLC

Marlborough, MA1 decision2014–20140 recalls

FDA records 1 decision for Omnyx, LLC (Marlborough, MA) in 2014: 1 510(k) clearance. All are in product code OEO (Automated Digital Image Manual Interpretation…). 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, hematology panel, where it files most

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

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Omnyx, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OEOAutomated Digital Image Manual Interpretation Microscope1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014

The one decision as Omnyx, LLC →