FDA applicant

Ino Therapeutics

Madison, WI13 decisions2005–20134 recalls

FDA records 13 decisions for Ino Therapeutics (Madison, WI) from 2005 to 2013: 13 510(k) clearances. Most are in product codes MRN (Apparatus, Nitric Oxide Delivery) and MRO (Apparatus, Nitric Oxide, Backup Delivery). Its devices cite 52 predicates, 43 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Ino Therapeutics, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2013

2007high 2 (2007) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Ino Therapeutics

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?

What has been recalled?