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Multiple Pharma-Plast Tracheal Tube

by Pharma-Plast USA, Inc.

510(k) K871263

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 NumberK871263 Date15 Jun 1987ClearedStatusActive

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  • Withdrawn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
BTR
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Multiple Pharma-Plast Tracheal Tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway. It is classified as a Tube, Tracheal (W/Wo Connector) with the FDA product code BTR.

The device is regulated under 21 CFR 868.5730 and has received FDA 510(k) clearance, specifically clearance K871263. It is supplied by Pharma-Plast USA, Inc. and is classified as a Class II device.

Other devices from Pharma-Plast USA, Inc.

See all devices from Pharma-Plast USA, Inc. →

Questions

AI-generated answers, 28 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 Multiple Pharma-Plast Tracheal Tube used for?

    The Multiple Pharma-Plast Tracheal Tube is used to maintain an open airway in patients, inserted via the nose or mouth.

  • What type of device is the Multiple Pharma-Plast Tracheal Tube?

    The device is classified as a Tube, Tracheal (W/Wo Connector) with the FDA product code BTR.

  • Is the Multiple Pharma-Plast Tracheal Tube supplied sterile?

    The device data does not specify if the tube is supplied sterile, it is regulated under 21 CFR 868.5730.

  • What is the regulatory classification of the Multiple Pharma-Plast Tracheal Tube?

    The device is classified as a Class II device and has received FDA 510(k) clearance, specifically clearance K871263.