510(k) Report

FDA applicant

Codan US Corp.

Santa Ana, CA7 decisions1999–20121 recall

FDA records 7 decisions for Codan US Corp. (Santa Ana, CA) from 1999 to 2012: 7 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KNT (Tubes, Gastrointestinal (And Accessories)). 1 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 hospital panel, where it files most

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

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Codan US Corp.’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?

  • FPASet, Administration, Intravascular5decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • LHISet, I.V. Fluid Transfer1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K021480Extension Set Light-Safe, Model BC565Codan US Corp. · 20022cite it
  • K033301IV Administration and Connect SetsCodan US Corp. · 20041cites it

What has FDA decided for it lately?

  • K112268Codan Safefeed Enteral Feeding ReservoirCodan US Corp. · 2012
  • K042693IV Administration Set B400 SPCodan US Corp. · 2004
  • K033301IV Administration and Connect SetsCodan US Corp. · 20041 recall
  • K021480Extension Set Light-Safe, Model BC565Codan US Corp. · 2002
  • K013714Codan US I.V. Administration Set, Model B400 SPCodan US Corp. · 2002
  • K001872I.V. Set-Luer Lock with Latex Free Injection Site, Model B411Codan US Corp. · 2000
  • K990711Codan ChemospikeCodan US Corp. · 1999

All 7 as Codan US Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033301CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220…Sep 12, 2019Class II

Other applicant names beginning “Codan”

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

Codan Medlon, Inc. 4Codan Trading Co. 1