510(k) Report

FDA applicant

Xlumena, Inc.

Mountain View, CA3 decisions2010–20141 recall

FDA records 3 decisions for Xlumena, Inc. (Mountain View, CA) from 2010 to 2014: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PCU (Pancreatic Stent, Covered, Metallic, Removable) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Xlumena”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2014

2010: 12013: 12014: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2010high 1 (2013) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Xlumena, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xlumena, 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?

  • PCUPancreatic Stent, Covered, Metallic, Removable2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • DEN130007Axios Stent and Delivery SystemXlumena, Inc. · 20132cite it
  • K140561Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM…Xlumena, Inc. · 20142cite it

What has FDA decided for it lately?

  • K140561Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM…Xlumena, Inc. · 2014
  • DEN130007Axios Stent and Delivery SystemXlumena, Inc. · 2013
  • K093279Navix Access DeviceXlumena · 20101 recall

All 2 as Xlumena, Inc. →The one decision as Xlumena →

What has been recalled?

1 recall linked to its devices; the latest:

  • K093279Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number…Apr 17, 2013Class II