510(k) Report

FDA applicant

Praxair Distribution, Incorporated.

Tonawanda, NY2 decisions2016–20186 recalls

FDA records 2 decisions for Praxair Distribution, Incorporated. (Tonawanda, NY) from 2016 to 2018: 2 510(k) clearances. Most are in product codes ECX (Cylinder, Compressed Gas, And Valve) and MRN (Apparatus, Nitric Oxide Delivery). Its devices cite 3 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Praxair Distribution, Inc.”.

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 Distribution, Incorporated.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2026

2023: 2, 1 Class I2025: 2, 2 Class I2026 (partial year): 2
2016high 2 (2023) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Praxair Distribution, Incorporated. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Praxair”

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