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Heated Breathing Tube

by GuangDong EDA Technology Co., Ltd.

510(k) K243244

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 NumberK243244 Date25 Jul 2025ClearedStatusActive

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  • Withdrawn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
BZE
Device Class
Class II
Regulation
21 CFR Part 868.5270
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Heated Breathing Tube is a Class II medical device designed for use in breathing systems. It is intended to provide heated air or gas during respiratory procedures, helping to maintain optimal temperature and humidity for patients.

This device is supplied as a single-use or reusable product depending on the specific model. It is MRI safe and comes in various sizes to accommodate different patient needs. The Heated Breathing Tube is authorized under FDA 510(k) clearance with product code BZE and regulation number 868.5270.

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Questions

AI-generated answers, 24 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 Heated Breathing Tube used for?

    The Heated Breathing Tube is designed for use in breathing systems to provide heated air or gas during respiratory procedures, helping to maintain optimal temperature and humidity for patients.

  • Is the Heated Breathing Tube single-use or reusable?

    The Heated Breathing Tube is supplied as either a single-use or reusable product depending on the specific model selected, allowing flexibility for different clinical needs and preferences.

  • What sizes are available for the Heated Breathing Tube?

    The Heated Breathing Tube comes in various sizes to accommodate different patient needs, ensuring proper fit and functionality across a range of clinical applications.

  • What is the regulatory status of the Heated Breathing Tube?

    The Heated Breathing Tube is authorized under FDA 510(k) clearance with product code BZE and regulation number 868.5270, classified as a Class II medical device.