Arcadia Medical Corporation
Appollo Beach, FL, US
Arcadia Medical Corporation appears in FDA device records in Appollo Beach, FL. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Arcadia Medical Corporation between 2003 and 2006. The busiest year on record is 2003, with 1. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060094 | ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | |
| K031553 | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES | BTO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1628-2012 | Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management. | A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula. | Terminated | ||
| Z-2657-2011 | Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management Arcadia Medical Corporation 1450 East American Lane, Schaumburg, IL 60173 USA Arcadia Medical Corporation Tortola, British Virgin Islands www.arcadiamedical.com, Made in USA | The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain