510(k) Report

FDA applicant

Vygon Corp.

East Rutherford, NJ53 decisions1985–202524 recalls

FDA records 53 decisions for Vygon Corp. (East Rutherford, NJ) from 1985 to 2025: 53 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 30 predicates, 14 of them its own earlier devices. 24 recalls are linked to its devices.

FDA’s records also spell it “Vygon SA”, “Vygon”, “Vygon Corporation”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2007: 12008: 12011: 12012: 12014: 12016: 12025: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2017

2010: 22011: 22013: 22014: 12015: 122017: 2
2007high 12 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days11decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days9decisions
  • FPDTube, Feeding4decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • FOSCatheter, Umbilical Artery3decisions
  • BSYCatheters, Suction, Tracheobronchial3decisions

Also: DYB (2), BTR (2), FPA (2), GAM (2), BRZ (1), FMI (1).

Whose devices does it build on?

Its devices cite 30 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 14 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.

  • K060944Nutrisafe 2Vygon Corp. · 20067cite it
  • K013884Boussignac C.P.a.P. DeviceVygon SA · 20034cite it
  • K925854Vygon - Enteral Feeding Tube - PolyurethaneVygon Corp. · 19943cite it
  • K941678BionectorVygon Corp. · 19952cite it
  • K991918Nutrisafe Extension TubeVygon Corp. · 19992cite it
  • K040657Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80Vygon SA · 20041cites it

What has FDA decided for it lately?

  • K241587pilot TLSVygon Corporation · 2025
  • K151237Nutrisafe 2- ENFit AdaptorVygon · 2016
  • K141026LeaderflexVygon · 2014
  • K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012
  • K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp. · 2011
  • K073493Hepatostat SetVygon Corp. · 2008
  • K070705Modification to: Latex-Free Bionector, Model# 896.019, 896.039Vygon Corp. · 200713 recalls
  • K061796Hepatostat Set, Model 760XVygon Corp. · 2006

All 48 as Vygon Corp. →All 2 as Vygon SA →All 2 as Vygon →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K060944Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352MJul 24, 2017Class II
  • K954302CVC Tray Pediatrics. Product Code: AMS-9335CP-2.Jul 24, 2017Class II
  • K0213958" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer…Jan 15, 2015Class II
  • K0213957" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to…Jan 15, 2015Class II
  • K0213954" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to…Jan 15, 2015Class II
  • K0213957" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to…Jan 15, 2015Class II

Other applicant names beginning “Vygon”

FDA records each applicant name separately; these may or may not be the same firm.

Vygon USA 4Vygon Us, LLC 3Vygon Neuro 1