510(k) Report

FDA applicant

Xodus Medical, Inc.

New Kensington, PA6 decisions2006–20263 recalls

FDA records 6 decisions for Xodus Medical, Inc. (New Kensington, PA) from 2006 to 2026: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and OCT (Anti Fog Solution And Accessories, Endoscopy). Its devices cite 6 predicates, 0 of them its own earlier devices. 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2007: 12008: 12018: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2019

2019: 3
2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Xodus 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • OCTAnti Fog Solution And Accessories, Endoscopy1decision
  • DWJSystem, Thermal Regulating1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • FTALight, Surgical, Accessories1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K063587Xodus Medical Anti-Fog SolutionXodus Medical, Inc. · 20071cites it
  • K053433Cautery Tip Cleaner, Model 30500Xodus Medical, Inc. · 20061cites it
  • K182080Scope Antifogging SystemXodus Medical, Inc. · 20181cites it
  • K081647Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  • K182080Scope Antifogging SystemXodus Medical, Inc. · 2018
  • K081647Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc. · 2008
  • K063587Xodus Medical Anti-Fog SolutionXodus Medical, Inc. · 2007
  • K053433Cautery Tip Cleaner, Model 30500Xodus Medical, Inc. · 20063 recalls
  • K053321Light Guard Light Handle and Light Handle CoverXodus Medical, Inc. · 2006

All 6 as Xodus Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K053433Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessorySep 19, 2019Class II
  • K053433Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessorySep 19, 2019Class II
  • K053433Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessorySep 19, 2019Class II