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Communi-Trach Tube

by Implant Technology, Inc.

510(k) K841546

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 NumberK841546 Date30 Apr 1984ClearedStatusActive

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  • Withdrawn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, 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.

A tracheostomy tube with or without connector, classified as a Class II medical device under the Anesthesiology specialty. It is a tube designed for tracheostomy procedures.

The device received traditional 510(k) clearance (K841546) on April 30, 1984, and is substantially equivalent to a predicate device. It is manufactured by Implant Technology, Inc. and is intended for use in clinical settings requiring tracheostomy tube support.

Other devices from Implant Technology, Inc.

See all devices from Implant Technology, Inc. →

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 is the COMMUNI-TRACH TUBE used for?

    The COMMUNI-TRACH TUBE is a tracheostomy tube designed for tracheostomy procedures, intended for use in clinical settings requiring tracheostomy tube support, as specified in its 510(k) clearance documentation.

  • Is the COMMUNI-TRACH TUBE supplied with or without a connector?

    The device is described as a tracheostomy tube with or without connector, meaning it may be supplied in configurations that include or exclude a connector, depending on the specific model or variant.

  • What regulatory pathway was used for the COMMUNI-TRACH TUBE?

    The COMMUNI-TRACH TUBE received traditional 510(k) clearance (K841546) on April 30, 1984, and was determined to be substantially equivalent to a predicate device under the FDA’s 510(k) process.

  • Who manufactures the COMMUNI-TRACH TUBE and where is it located?

    The COMMUNI-TRACH TUBE is manufactured by Implant Technology, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as indicated in the device’s registration and address fields.