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Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal And Pediatric Tracheostomy Tubes

by Arcadia Medical Corporation

510(k) K031553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031553 Date18 Nov 2003ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1628-2012 FDA Not yet classified initiated 18 Apr 2012

    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 FDA Unclassified (pre-2012) initiated 8 May 2011

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a tracheostomy tube, specifically designed for neonatal and pediatric use, made of silicone and available in both cuffed and cuffless variations. It is intended to provide a secure airway for patients requiring tracheostomy. The device is designed to conform to the patient's trachea after insertion, distributing pressure over a maximum surface area.

The device is supplied in various sizes and is designed for single-use. It is made of silicone, which is gentle on the tracheal mucosa and the stoma itself. The device is regulated under the product code BTO and has the regulation number 868.5800. It has been authorized by the FDA under the 510K clearance type.

Other devices from Arcadia Medical Corporation

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the silicone tracheostomy tubes used for?

    The tubes are intended to provide a secure airway for patients requiring tracheostomy, specifically designed for neonatal and pediatric use.

  • Are the tracheostomy tubes supplied in different sizes?

    Yes, the device is supplied in various sizes to accommodate different patient needs.

  • Are the tracheostomy tubes reusable?

    No, the device is designed for single-use, ensuring patient safety and reducing the risk of infection.

  • What material are the tracheostomy tubes made of?

    The tubes are made of silicone, which is gentle on the tracheal mucosa and the stoma itself.