Data / Medical devices / United States / Codan Us Corp.
Codan Us Corp.: FDA-registered device maker in Santa Ana, CA, United States, 9 510(k) clearances
Codan Us Corp. is registered with the FDA (registration 2016945) in Santa Ana, CA, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 19, 2012. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2016945
- Address
- 3501 West Sunflower Ave., Santa Ana, CA, United States, 92704
- Owner or operator
- CODAN US Corporation (8010060)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- BBG, CODAN, CODAN CYTO, CODAN LIGHT-SAFE, CODAN Vial Spike, Enteral Feeding sets, SafeFeed Enteral Feeding Reservoir, WALRUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2012 | K112268 | CODAN SAFEFEED ENTERAL FEEDING RESERVOIR | KNT | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| November 25, 2008 | K082654 | ENTERAL ONLY EXTENSION SET | KNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 21, 2004 | K042693 | IV ADMINISTRATION SET B400 SP | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| March 4, 2004 | K033301 | IV ADMINISTRATION AND CONNECT SETS | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| June 27, 2002 | K021480 | EXTENSION SET LIGHT-SAFE, MODEL BC565 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| April 13, 1999 | K990711 | CODAN CHEMOSPIKE | LHI | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| April 17, 1996 | K960921 | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE | LHI | Substantially Equivalent | Codan Medlon, Inc. | accessdata.fda.gov |
| April 28, 1983 | K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | FPA | Substantially Equivalent | Medical Parameters, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2019 | 85367 | Class II | Terminated | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA. | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. | accessdata.fda.gov |
| August 17, 2011 | 68591 | Class II | Terminated | ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408 | CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Administration, Intravascular
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Updated June 26, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.