510(k) Report

FDA applicant

Oxus, Inc.

Auburn Hills, MI2 decisions2017–20231 recall

FDA records 2 decisions for Oxus, Inc. (Auburn Hills, MI) from 2017 to 2023: 2 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Oxus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12023: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2017high 1 (2025) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Oxus, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oxus, Inc.’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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Which product codes does it file in?

  • CAWGenerator, Oxygen, Portable2decisions

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 2 times; 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.

  • K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 20172cite it

What has FDA decided for it lately?

  • K211056Oxus Sieve BedsOxus, Inc. · 2023
  • K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 20171 recall

All 2 as Oxus, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K162433GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SMay 8, 2025Class II