510(k) Report

FDA applicant

Corpak Medsystems

Wheeling, IL15 decisions1982–20143 recalls

FDA records 15 decisions for Corpak Medsystems (Wheeling, IL) from 1982 to 2014: 15 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FPD (Tube, Feeding). 3 recalls are linked to its devices, 1 Class I.

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 Corpak Medsystems’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2008: 12009: 52010: 12012: 12013: 12014: 2
2007high 5 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2012: 12017: 12022: 1, 1 Class I
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Corpak Medsystems 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?

  • KNTTubes, Gastrointestinal (And Accessories)9decisions
  • FPDTube, Feeding4decisions
  • PIFGastrointestinal Tubes With Enteral Specific Connectors1decision
  • OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position1decision

Who builds on its devices?

Later devices cite its devices 16 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.

  • K083210Corflo Anti IV Enteral Feeding TubeCorpak Medsystems · 20083cite it
  • K821906Corpak Enteric Feeding Tube W/Guide TipCorpak Medsystems · 19823cite it
  • K113351Cortrak Enteral Access DeviceCorpak Medsystems · 20122cite it
  • K831328Neonatal Nasogastric Feeding Tube-Corpak Medsystems · 19832cite it
  • K083786Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LBCorpak Medsystems · 20092cite it
  • K142012Farrell Valve System with Equilibrium Technology and Enfit Enteral ConnectorsCorpak Medsystems · 20141cites it

What has FDA decided for it lately?

  • K142012Farrell Valve System with Equilibrium Technology and Enfit Enteral ConnectorsCorpak Medsystems · 2014
  • K133599CorgripCorpak Medsystems · 2014
  • K131532Electromagnetic Transmitting StyletCorpak Medsystems · 2013
  • K113351Cortrak Enteral Access DeviceCorpak Medsystems · 20121 Class I recall
  • K100365Farrell Valve with Corflo Anti-IV Connectors Model 20-4300AIVCorpak Medsystems · 2010
  • K091637Cortrak Enteral Access Device, Model 20-0900Corpak Medsystems · 2009
  • K083776Corflo Anti IV Enteral Feeding Set, Model: 20-1030AIV-LB-SCorpak Medsystems · 2009
  • K083791Corflo Anti IV Enteral Feeding Set, Model: 20-1060AIV-SCorpak Medsystems · 2009

All 15 as Corpak Medsystems →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K191340Avanos Cortrak 2 Enteral Access System (EAS)Mar 21, 2022Class I
  • K083210CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic…Dec 13, 2017Class II
  • K821906CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max…Jan 26, 2012

Other applicant names beginning “Corpak”

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

Corpak Co. 24Corpak Medsystems, Inc. A Division of Haylard Health 1