510(k) Report

FDA applicant

Praxair, Inc.

Tonawanda, NY2 decisions2005–20204 recalls

FDA records 2 decisions for Praxair, Inc. (Tonawanda, NY) from 2005 to 2020: 2 510(k) clearances. Most are in product codes BZR (Mixer, Breathing Gases, Anesthesia Inhalation) and MRN (Apparatus, Nitric Oxide Delivery). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices, 2 Class I.

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 Praxair, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2025: 2, 2 Class I2026 (partial year): 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Praxair, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision
  • MRNApparatus, Nitric Oxide Delivery1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 20201cites it

What has FDA decided for it lately?

  • K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 20202 Class I recalls
  • K051192Praxair Medical Air MixerPraxair, Inc. · 2005

All 2 as Praxair, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K171696NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Sep 14, 2026Class II
  • K171696NOxBOXi Nitric Oxide Delivery System.Aug 19, 2026Class II
  • K171696NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISep 9, 2025Class I
  • K171696NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISep 9, 2025Class I

Other applicant names beginning “Praxair”

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

Praxair Distribution, Incorporated. 2Praxair Healthcare Services 1