Atlas FDA

BZE

46 FDA 510(k) clearances · Product code

176 daysmedian time to decision
380 days90th percentile
46clearances measured

FDA profile

Official device name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5270
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 124 · 2022: 152 · 2023: 125 · 2024: 172 · 2025: 195 · 2026: 114
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20) (K252066)Vincent Healthcare Products Limited2026-06-18
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, LP2026-03-25
Heated Breathing Tube (K243244)Guangdong Eda Technology Co., Ltd.2025-07-25
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (K241268)Exceleron Medical2024-08-02
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 (K234032)Medline Industries, LP2024-06-04
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (K222822)Draegerwerk AG & CO Kgaa2023-06-14
Sunset Heated CPAP Tube (K201418)Sunset Healthcare Solutions, Inc.2021-01-29
Neonatal ConchaSmart Breathing Circuits (K173280)Teleflexmedical, Inc.2018-08-02
AirLife Adult Heated Wire BiPAP/NIV Circuit (K170378)Vyaire Medical2017-09-14
AirLife Adult Heated Wire Circuit (K153234)Carefusion, Inc.2016-07-07
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540)Flexicare Medical Limited.2016-06-23
Hybernite RT (K151461)Plastiflex Group NV2016-03-24
AirLife Infant Heated Wire Circuit (K151303)Care Fusion2016-01-21
AirLife Infant Single Limb Heated Wire Circuit (K151959)Carefusion, Inc.2016-01-20
Flexicare Heated Wire Breathing Systems (K150900)Flexicare Medical, Ltd.2015-05-15
RESPIRONICS REUSABLE HEATED TUBING (K140424)Respironics, Inc.2014-11-14
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS (K122432)Fisher & Paykel Healthcare, Ltd.2012-12-06
DUAL HEATED INFANT VREATHING CIROUITS (K103767)Fisher & Paykel Healthcare, Ltd.2012-04-16
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS (K110398)Respironics, Inc.2011-06-01
INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 (K092129)Intersurgical, Inc.2010-05-18
HYBERNITE RAINOUT CONTROL SYSTEM (K100104)Plastiflex Group NV2010-04-14
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS (K034026)Fisher & Paykel Healthcare, Ltd.2005-01-12
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS (K000697)Allegiance Healthcare Corp.2000-03-30
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS (K993833)Allegiance Healthcare Corp.1999-12-10
CRITERION, CRITERION I.V., MODIFIED (K952267)Nova-Ventrx1997-12-02
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (K962220)Marquest Medical Products, Inc.1997-01-14
HPD HEATER BASES (K914994)Hpd Medical, Inc.1993-02-12
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT (K915226)Baxter Healthcare Corp1993-01-12
FLEXHTR-1 (K894654)Bird Products Corp.1990-08-01
PROTOLOGIC MODEL SER-1 (K894936)Protologic, Inc.1990-01-22
BREATHING CIRCUIT W/HEATED WIRE (K880769)Dryden Corp.1988-08-24
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT (K881231)Intertech Resources, Inc.1988-07-01
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (K881625)Respiratory Care, Inc.1988-06-21
SIMPLEX UNIVERSAL HEATED TUBING SLEEVE (K881451)Simplex Medical Corp.1988-06-10
VAPOR-PHASE HEATED WIRE CONTROLLER (K881137)Advanced Research Technologies, Inc.1988-04-27
HEATER WIRE BREATHING CIRCUIT (K873179)Life Design Systems, Inc.1988-03-31
DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (K860941)Intec Medical, Inc.1986-04-02
ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY (K851245)Applinc1985-05-15
RESPIRATORY GAS HUMIDIFIER (K842597)Applinc1985-01-16
ARM-A-VIAL LV HEATER-BREATHING SYS (K844005)Armour Pharmaceutical Co.1984-11-08
TROPIC AIR HEAT-ECHANGER BREATHING AID (K821735)Tropic Air1982-09-07
ANALOR FOUR-ORAL SURGERY MODEL (K801101)Narco Mckesson Co.1980-06-17
TEMPERATURE CONTROLLER MODEL 17000 (K781530)Healthdyne, Inc.1978-11-14
CONTROLLER, SERVO, INSPIRON (K780630)C.R. Bard, Inc.1978-05-31
TA-2 TEMPERATURE ALARM (K770984)Mistogen Equipment Co.1977-07-05
RESP. AIR TEMP. CONTROL & HAZARD MON. (K761295)Harris-Lake, Inc.1976-12-30

Track BZE automatically

Every clearance here is in the API, with alerts when new ones post.