510(k) Report

FDA applicant

Ino Therapeutics/Ikaria

Madison, WI2 decisions2013–20154 recalls

FDA records 2 decisions for Ino Therapeutics/Ikaria (Madison, WI) from 2013 to 2015: 2 510(k) clearances. All are in product code MRN (Apparatus, Nitric Oxide Delivery). Its devices cite 14 predicates, 1 of them its own earlier devices. 4 recalls are 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/Ikaria’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2014: 22016: 12018: 1
2013high 2 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Ino Therapeutics/Ikaria by year, 2013–2026Sources: 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 14 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K131686Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 20133cite it

What has FDA decided for it lately?

  • K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria · 2015
  • K131686Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 20134 recalls

All 2 as Ino Therapeutics/Ikaria →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K131686Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device…Jul 9, 2018Class II
  • K131686Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers…Nov 21, 2016Class II
  • K131686INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers…Oct 17, 2014Class II
  • K131686INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The…Mar 27, 2014Class II