510(k) Report

FDA applicant

Xylos Corporation

Langhorne, PA9 decisions1998–20110 recalls

FDA records 9 decisions for Xylos Corporation (Langhorne, PA) from 1998 to 2011: 9 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 23 predicates, 10 of them its own earlier devices. No 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2008: 12009: 32010: 12011: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • FTMMesh, Surgical6decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • OMRVessel Guard Or Cover1decision

Whose devices does it build on?

Its devices cite 23 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 10 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.

  • K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 20033cite it
  • K974251X-Cell Wound DressingXylos Corporation · 19983cite it
  • K081882Modification to Xylos Surgical MeshXylos Corporation · 20083cite it
  • K083823Securian Tissue Reinforcement MatrixXylos Corporation · 20092cite it
  • K090778Mta Protective SheetXylos Corporation · 20092cite it
  • K023237Xylos Surgical MeshXylos Corporation · 20032cite it

What has FDA decided for it lately?

  • K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
  • K100984Xylos Vessel GuardXylos Corporation · 2010
  • K090880Xylos Porous Surgical MeshXylos Corporation · 2009
  • K090778Mta Protective SheetXylos Corporation · 2009
  • K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009
  • K081882Modification to Xylos Surgical MeshXylos Corporation · 2008
  • K023237Xylos Surgical MeshXylos Corporation · 2003
  • K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003

All 9 as Xylos Corporation →