510(k) Report

FDA applicant

Arcadia Medical Corporation

Appollo Beach, FL2 decisions2003–20062 recalls

FDA records 2 decisions for Arcadia Medical Corporation (Appollo Beach, FL) from 2003 to 2006: 2 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and BTR (Tube, Tracheal (W/Wo Connector)). Its devices cite 8 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Arcadia Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arcadia Medical Corporation since 2007.

Recalls per year

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arcadia Medical Corporation 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?

  • BTOTube, Tracheostomy (W/Wo Connector)1decision
  • BTRTube, Tracheal (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy TubesArcadia Medical Corporation · 20031cites it

What has FDA decided for it lately?

  • K060094Arcadia Medical Silicone Wire Reinforced Endotracheal TubesArcadia Medical Corporation · 2006
  • K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy TubesArcadia Medical Corporation · 20032 recalls

All 2 as Arcadia Medical Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K031553Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange…Apr 18, 2012
  • K031553Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire…May 8, 2011