Product Code: BZE
FDA class 2
21 CFR 868.5270
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Anesthesiology
The Heater, Breathing System W/Wo Controller is a device that warms gases within a respiratory breathing circuit to prevent hypothermia of the airways and maintain appropriate gas temperatures during ventilation; it is distinct from humidifiers and nebulizers. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BZE, regulated under 21 CFR 868.5270 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
46
FEI Numbers
49
Registration Numbers
49
Unique Applicants
38
Years Active
49
Basic Information
- Product Code
- BZE
- Device Class
- FDA class 2
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 46 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252066 | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | Jun 18, 2026 | Substantially Equivalent | Vincent Healthcare Products Limited |
| K253322 | 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) | Mar 25, 2026 | Substantially Equivalent | Medline Industries, LP |
| K243244 | Heated Breathing Tube | Jul 25, 2025 | Substantially Equivalent | Guangdong Eda Technology Co., Ltd. |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Aug 02, 2024 | Substantially Equivalent | Exceleron Medical |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | Jun 04, 2024 | Substantially Equivalent | Medline Industries, LP |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Jun 14, 2023 | Substantially Equivalent | Draegerwerk AG & CO Kgaa |
| K201418 | Sunset Heated CPAP Tube | Jan 29, 2021 | Substantially Equivalent | Sunset Healthcare Solutions, Inc. |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Aug 02, 2018 | Substantially Equivalent | Teleflexmedical, Inc. |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Sep 14, 2017 | Substantially Equivalent | Vyaire Medical |
| K153234 | AirLife Adult Heated Wire Circuit | Jul 07, 2016 | Substantially Equivalent | Carefusion, Inc. |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Jun 23, 2016 | Substantially Equivalent | Flexicare Medical Limited. |
| K151461 | Hybernite RT | Mar 24, 2016 | Substantially Equivalent | Plastiflex Group NV |
| K151303 | AirLife Infant Heated Wire Circuit | Jan 21, 2016 | Substantially Equivalent | Care Fusion |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Jan 20, 2016 | Substantially Equivalent | Carefusion, Inc. |
| K150900 | Flexicare Heated Wire Breathing Systems | May 15, 2015 | Substantially Equivalent | Flexicare Medical, Ltd. |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Nov 14, 2014 | Substantially Equivalent | Respironics, Inc. |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Dec 06, 2012 | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Apr 16, 2012 | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Jun 01, 2011 | Substantially Equivalent | Respironics, Inc. |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | May 18, 2010 | Substantially Equivalent | Intersurgical, Inc. |
| K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | Apr 14, 2010 | Substantially Equivalent | Plastiflex Group NV |
| K034026 | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | Jan 12, 2005 | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. |
| K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | Mar 30, 2000 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | Dec 10, 1999 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Dec 02, 1997 | Substantially Equivalent | Nova-Ventrx |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | Jan 14, 1997 | Substantially Equivalent | Marquest Medical Products, Inc. |
| K914994 | HPD HEATER BASES | Feb 12, 1993 | Substantially Equivalent | Hpd Medical, Inc. |
| K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | Jan 12, 1993 | Substantially Equivalent | Baxter Healthcare Corp |
| K894654 | FLEXHTR-1 | Aug 01, 1990 | Substantially Equivalent | Bird Products Corp. |
| K894936 | PROTOLOGIC MODEL SER-1 | Jan 22, 1990 | Substantially Equivalent | Protologic, Inc. |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Aug 24, 1988 | Substantially Equivalent | Dryden Corp. |
| K881231 | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT | Jul 01, 1988 | Substantially Equivalent | Intertech Resources, Inc. |
| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | Jun 21, 1988 | Substantially Equivalent | Respiratory Care, Inc. |
| K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE | Jun 10, 1988 | Substantially Equivalent | Simplex Medical Corp. |
| K881137 | VAPOR-PHASE HEATED WIRE CONTROLLER | Apr 27, 1988 | Substantially Equivalent | Advanced Research Technologies, Inc. |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Mar 31, 1988 | Substantially Equivalent | Life Design Systems, Inc. |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | Apr 02, 1986 | Substantially Equivalent | Intec Medical, Inc. |
| K851245 | ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY | May 15, 1985 | Substantially Equivalent | Applinc |
| K842597 | RESPIRATORY GAS HUMIDIFIER | Jan 16, 1985 | Substantially Equivalent | Applinc |
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | Nov 08, 1984 | Substantially Equivalent | Armour Pharmaceutical Co. |
| K821735 | TROPIC AIR HEAT-ECHANGER BREATHING AID | Sep 07, 1982 | Substantially Equivalent | Tropic Air |
| K801101 | ANALOR FOUR-ORAL SURGERY MODEL | Jun 17, 1980 | Substantially Equivalent | Narco Mckesson Co. |
| K781530 | TEMPERATURE CONTROLLER MODEL 17000 | Nov 14, 1978 | Substantially Equivalent | Healthdyne, Inc. |
| K780630 | CONTROLLER, SERVO, INSPIRON | May 31, 1978 | Substantially Equivalent | C.R. Bard, Inc. |
| K770984 | TA-2 TEMPERATURE ALARM | Jul 05, 1977 | Substantially Equivalent | Mistogen Equipment Co. |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | Dec 30, 1976 | Substantially Equivalent | Harris-Lake, Inc. |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.