510(k) Report

FDA applicant

Ino Therapeutics, LLC/Dba Ikaria

Port Allen, LA2 decisions2011–20120 recalls

FDA records 2 decisions for Ino Therapeutics, LLC/Dba Ikaria (Port Allen, LA) from 2011 to 2012: 2 510(k) clearances. All are in product code MRN (Apparatus, Nitric Oxide Delivery). Its devices cite 18 predicates, 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Ino Therapeutics, LLC/Dba Ikaria by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRNApparatus, Nitric Oxide Delivery2decisions

Whose devices does it build on?

Its devices cite 18 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110635Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria · 20114cite it
  • K113272Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 20123cite it

What has FDA decided for it lately?

  • K113272Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 2012
  • K110635Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria · 2011

All 2 as Ino Therapeutics, LLC/Dba Ikaria →