Cleared Traditional

Heated Breathing Tube

K243244 · Guangdong Eda Technology Co., Ltd. · Anesthesiology

Jul 2025

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K243244 is an FDA 510(k) clearance for the Heated Breathing Tube, a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Guangdong Eda Technology Co., Ltd. (Guangdong Province, CN). The FDA issued a Cleared decision on July 25, 2025, 287 days after receiving the submission on October 11, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number	K243244 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2024
Decision Date	July 25, 2025
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5270