BZE · Class II · 21 CFR 868.5270

FDA Product Code BZE: Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

Leading manufacturers include Medline Industries, LP, Teleflexmedical, Inc. and Sunset Healthcare Solutions, Inc..

45
Total
45
Cleared
189d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 184d avg (recent)

FDA 510(k) Cleared Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer Devices (Product Code BZE)

45 devices
1–24 of 45
Cleared Mar 25, 2026
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
K253322
Medline Industries, LP
Anesthesiology · 176d
Cleared Jul 25, 2025
Heated Breathing Tube
K243244
Guangdong Eda Technology Co., Ltd.
Anesthesiology · 287d
Cleared Aug 02, 2024
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
K241268
Exceleron Medical
Anesthesiology · 88d
Cleared Jun 04, 2024
Hudson RCI Dri-Tech Breathing Circuits
K234032
Medline Industries, LP
Anesthesiology · 167d
Cleared Jun 14, 2023
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
K222822
Draegerwerk AG & CO Kgaa
Anesthesiology · 268d
Cleared Jan 29, 2021
Sunset Heated CPAP Tube
K201418
Sunset Healthcare Solutions, Inc.
Anesthesiology · 245d
Cleared Aug 02, 2018
Neonatal ConchaSmart Breathing Circuits
K173280
Teleflexmedical, Inc.
Anesthesiology · 290d
Cleared Jan 12, 1993
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226
Baxter Healthcare Corp
Anesthesiology · 419d
Cleared May 31, 1978
CONTROLLER, SERVO, INSPIRON
K780630
C.R. Bard, Inc.
Anesthesiology · 44d

About Product Code BZE - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code BZE since 1976, with 45 receiving FDA clearance (average review time: 189 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BZE Product Code

FDA review times for BZE submissions have been consistent, averaging 184 days recently vs 190 days historically.

BZE devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →