510(k) Report

FDA applicant

Oxos Medical, Inc.

Atlanta, GA5 decisions2021–20251 recall

FDA records 5 decisions for Oxos Medical, Inc. (Atlanta, GA) from 2021 to 2025: 5 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Oxos Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Oxos Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 22022: 12024: 12025: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2021high 1 (2026) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Oxos Medical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oxos Medical, 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?

  • IZLSystem, X-Ray, Mobile3decisions
  • OWBInterventional Fluoroscopic X-Ray System2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 165 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203658Micro C Medical Imaging System, M01Oxos Medical, Inc. · 20211cites it
  • K241567MC2 Portable X-ray SystemOxos Medical · 20241cites it
  • K211473Micro C Medical Imaging System, M01Oxos Medical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K252068MC2 Portable X-ray SystemOxos Medical · 20251 recall
  • K241567MC2 Portable X-ray SystemOxos Medical · 2024
  • K212654Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2022
  • K211473Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021
  • K203658Micro C Medical Imaging System, M01Oxos Medical, Inc. · 2021

All 3 as Oxos Medical, Inc. →All 2 as Oxos Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K252068Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog…Jun 11, 2026Class II