# Vygon Corp.

- Location (FDA's records): East Rutherford, NJ
- FDA decisions: 53 (1985–2025): 53 510(k) clearances
- Names in FDA's records: Vygon Corp. (48); Vygon SA (2); Vygon (2); Vygon Corporation (1)
- Product codes: LJS (11), FOZ (9), FPD (4), KNT (4), FOS (3), BSY (3), DYB (2), BTR (2), FPA (2), GAM (2), BRZ (1), FMI (1)
- Predicates its devices cite: 30 (14 its own); citations of its devices by later devices: 33 (14 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Vital Signs, Inc.: 2 (https://510kreport.com/company/vital-signs)
- National Catheter Co. Div. Mallinckrodt: 1 (https://510kreport.com/company/national-catheter-co-div-mallinckrodt)
- Medical Components, Inc. (dba MedComp): 1 (https://510kreport.com/company/medical-components-dba-medcomp)
- Cedic S.R.L.: 1 (https://510kreport.com/company/cedic)
- Mar-Med Co.: 1 (https://510kreport.com/company/mar-med)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)

## Firms that cite its devices most
- Vygon USA: 2 (https://510kreport.com/company/vygon-usa)
- Philips Children'S Medical Ventures: 1 (https://510kreport.com/company/philips-children-s-medical-ventures)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Benlan, Inc.: 1 (https://510kreport.com/company/benlan)
- Neomed, Inc.: 1 (https://510kreport.com/company/neomed)
- Mercury Medical: 1 (https://510kreport.com/company/mercury-medical)
- Smiths Medical International, Ltd.: 1 (https://510kreport.com/company/smiths-medical-international)
- Sen MU Technology Co., Ltd.: 1 (https://510kreport.com/company/sen-mu-technology)

## Its most-cited devices
- K060944: Nutrisafe 2 (2006), cited by 7
- K013884: Boussignac C.P.a.P. Device (2003), cited by 4
- K925854: Vygon - Enteral Feeding Tube - Polyurethane (1994), cited by 3
- K941678: Bionector (1995), cited by 2
- K991918: Nutrisafe Extension Tube (1999), cited by 2
- K040657: Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80 (2004), cited by 1

## Recent decisions
- K241587: pilot TLS (Feb 26, 2025)
- K151237: Nutrisafe 2- ENFit Adaptor (Feb 9, 2016)
- K141026: Leaderflex (Jul 30, 2014)
- K121105: Nutrisafe 2 Feeding Tube (Dec 18, 2012)
- K100163: Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX (Oct 13, 2011)
- K073493: Hepatostat Set (May 6, 2008)
- K070705: Modification to: Latex-Free Bionector, Model# 896.019, 896.039 (Nov 30, 2007)
- K061796: Hepatostat Set, Model 760X (Nov 2, 2006)

Source page: https://510kreport.com/company/vygon