Panels › Anesthesiology › Product code BZE · Class 2
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation 868.5270
2510(k)s in 12 months (46 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in BZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Carefusion 2200 Inc | 0 | 4 |
| Fisher & Paykel Healthcare, Ltd. | 3 | 0 |
| Vyaire Medical | 1 | 2 |
| Allegiance Healthcare Corp. | 2 | 0 |
| Applinc | 2 | 0 |
| Carefusion, Inc. | 2 | 0 |
| Flexicare Medical Limited. | 2 | 0 |
| Medline Industries, LP | 2 | 0 |
| Plastiflex Group NV | 2 | 0 |
| Respironics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K252066 | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidif Vincent Healthcare Products Limited, HK | BZE |
| Mar 25, 2026 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech wi Medline Industries, LP | BZE |
| Jul 25, 2025 | K243244 | Heated Breathing Tube Guangdong Eda Technology Co., Ltd., CN | BZE |
| Aug 2, 2024 | K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) Exceleron Medical | BZE |
| Jun 4, 2024 | K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD9909 Medline Industries, LP | BZE |
| Jun 14, 2023 | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) Draegerwerk AG & CO Kgaa, DE | BZE |
| Jan 29, 2021 | K201418 | Sunset Heated CPAP Tube Sunset Healthcare Solutions, Inc. | BZE |
| Aug 2, 2018 | K173280 | Neonatal ConchaSmart Breathing Circuits Teleflexmedical, Inc. | BZE |
| Sep 14, 2017 | K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit Vyaire Medical | BZE |
| Jul 7, 2016 | K153234 | AirLife Adult Heated Wire Circuit Carefusion, Inc. | BZE |
| Jun 23, 2016 | K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM Flexicare Medical Limited., GB | BZE |
| Mar 24, 2016 | K151461 | Hybernite RT Plastiflex Group NV, BE | BZE |
| Jan 21, 2016 | K151303 | AirLife Infant Heated Wire Circuit Care Fusion | BZE |
| Jan 20, 2016 | K151959 | AirLife Infant Single Limb Heated Wire Circuit Carefusion, Inc. | BZE |
| May 15, 2015 | K150900 | Flexicare Heated Wire Breathing Systems Flexicare Medical, Ltd., GB | BZE |
| Nov 14, 2014 | K140424 | RESPIRONICS REUSABLE HEATED TUBING Respironics, Inc. | BZE |
| Dec 6, 2012 | K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS Fisher & Paykel Healthcare, Ltd., NZ | BZE |
| Apr 16, 2012 | K103767 | DUAL HEATED INFANT VREATHING CIROUITS Fisher & Paykel Healthcare, Ltd., NZ | BZE |
| Jun 1, 2011 | K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS Respironics, Inc. | BZE |
| May 18, 2010 | K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 Intersurgical, Inc. | BZE |
| Apr 14, 2010 | K100104 | HYBERNITE RAINOUT CONTROL SYSTEM Plastiflex Group NV | BZE |
| Jan 12, 2005 | K034026 | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS Fisher & Paykel Healthcare, Ltd., NZ | BZE |
| Mar 30, 2000 | K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS Allegiance Healthcare Corp. | BZE |
| Dec 10, 1999 | K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS Allegiance Healthcare Corp. | BZE |
| Dec 2, 1997 | K952267 | CRITERION, CRITERION I.V., MODIFIED Nova-Ventrx | BZE |
| Jan 14, 1997 | K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER Marquest Medical Products, Inc. | BZE |
| Feb 12, 1993 | K914994 | HPD HEATER BASES Hpd Medical, Inc. | BZE |
| Jan 12, 1993 | K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT Baxter Healthcare Corp | BZE |
| Aug 1, 1990 | K894654 | FLEXHTR-1 Bird Products Corp. | BZE |
| Jan 22, 1990 | K894936 | PROTOLOGIC MODEL SER-1 Protologic, Inc. | BZE |
| Aug 24, 1988 | K880769 | BREATHING CIRCUIT W/HEATED WIRE Dryden Corp. | BZE |
| Jul 1, 1988 | K881231 | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT Intertech Resources, Inc. | BZE |
| Jun 21, 1988 | K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL Respiratory Care, Inc. | BZE |
| Jun 10, 1988 | K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE Simplex Medical Corp. | BZE |
| Apr 27, 1988 | K881137 | VAPOR-PHASE HEATED WIRE CONTROLLER Advanced Research Technologies, Inc. | BZE |
| Mar 31, 1988 | K873179 | HEATER WIRE BREATHING CIRCUIT Life Design Systems, Inc. | BZE |
| Apr 2, 1986 | K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 Intec Medical, Inc. | BZE |
| May 15, 1985 | K851245 | ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY Applinc | BZE |
| Jan 16, 1985 | K842597 | RESPIRATORY GAS HUMIDIFIER Applinc | BZE |
| Nov 8, 1984 | K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS Armour Pharmaceutical Co. | BZE |
| Sep 7, 1982 | K821735 | TROPIC AIR HEAT-ECHANGER BREATHING AID Tropic Air | BZE |
| Jun 17, 1980 | K801101 | ANALOR FOUR-ORAL SURGERY MODEL Narco Mckesson Co. | BZE |
| Nov 14, 1978 | K781530 | TEMPERATURE CONTROLLER MODEL 17000 Healthdyne, Inc. | BZE |
| May 31, 1978 | K780630 | CONTROLLER, SERVO, INSPIRON C.R. Bard, Inc. | BZE |
| Jul 5, 1977 | K770984 | TA-2 TEMPERATURE ALARM Mistogen Equipment Co. | BZE |
| Dec 30, 1976 | K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. Harris-Lake, Inc. | BZE |
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