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Fome-Cuf Tracheal Tubes W/Sideport Airway Connect.

by Bivona Medical Technologies

510(k) K884427

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK884427 Date2 Nov 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 19 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 Fome-Cuf Tracheal Tubes with Sideport Airway Connect are silicone tracheostomy tubes designed for airway management in patients requiring tracheostomy. These tubes feature an auto-expanding foam cuff that conforms to the tracheal wall, distributing pressure over a broad surface area to minimize trauma and enhance patient comfort.

Supplied sterile in individual packaging, each kit includes an obturator, SidePort AutoControl airway connector, cuff inflation controller, twill tracheostomy tie, and a 15 mm disconnect wedge. The devices are classified as Class II under FDA regulations (21 CFR 868.5800) and are intended for single-use. Multiple sizes are available, as referenced in the FDA registration numbers, and are intended for use in clinical settings such as intensive care units and operating rooms.

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