FDA Product Code BZE: Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Leading manufacturers include Fisher &Paykel Healthcare , Ltd., Allegiance Healthcare Corp. and Respironics, Inc..
46
Total
46
Cleared
193d
Avg days
1976
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg
272d
recently vs 187d historically
FDA 510(k) Cleared Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer Devices (Product Code BZE)
46 devices
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)
Medline Industries, LP
Anesthesiology
176d
Cleared
Jul 25, 2025
Heated Breathing Tube
Guangdong Eda Technology Co., Ltd.
Anesthesiology
287d
Cleared
Aug 02, 2024
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Exceleron Medical
Anesthesiology
88d
Cleared
Jun 04, 2024
Hudson RCI Dri-Tech Breathing Circuits
Medline Industries, LP
Anesthesiology
167d
Cleared
Jun 14, 2023
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
Draegerwerk AG & CO Kgaa
Anesthesiology
268d
Cleared
Jan 29, 2021
Sunset Heated CPAP Tube
Sunset Healthcare Solutions, Inc.
Anesthesiology
245d
Cleared
Aug 02, 2018
Neonatal ConchaSmart Breathing Circuits
Teleflexmedical, Inc.
Anesthesiology
290d
Cleared
Nov 14, 2014
RESPIRONICS REUSABLE HEATED TUBING
Respironics, Inc.
Anesthesiology
268d
Cleared
Dec 06, 2012
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
118d
Cleared
Apr 16, 2012
DUAL HEATED INFANT VREATHING CIROUITS
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
480d
Cleared
Jun 01, 2011
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
Respironics, Inc.
Anesthesiology
110d
Cleared
Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
380d
Cleared
Mar 30, 2000
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
Allegiance Healthcare Corp.
Anesthesiology
29d
Cleared
Dec 10, 1999
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
Allegiance Healthcare Corp.
Anesthesiology
28d
Cleared
Jan 12, 1993
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
Baxter Healthcare Corp
Anesthesiology
419d
Cleared
Aug 01, 1990
FLEXHTR-1
Bird Products Corp.
Anesthesiology
373d
Cleared
May 31, 1978
CONTROLLER, SERVO, INSPIRON
C.R. Bard, Inc.
Anesthesiology
44d
About Product Code BZE - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code BZE since 1976, with 46 receiving FDA clearance (average review time: 193 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA 510(k) Review Time - BZE Product Code
Recent submissions under BZE have taken an average of 272 days to reach a decision - up from 187 days historically. Manufacturers should account for longer review timelines in current project planning.
BZE devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →