FDA Product Code
FDA Product Code BZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5270
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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) | Vincent Healthcare Products Limited | 2026-06-18 | Traditional | PDF ↗ |
| 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) | Medline Industries, LP | 2026-03-25 | Traditional | PDF ↗ |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025-07-25 | Traditional | PDF ↗ |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024-08-02 | Traditional | PDF ↗ |
| 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 | Medline Industries, LP | 2024-06-04 | Traditional | PDF ↗ |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | 2023-06-14 | Traditional | PDF ↗ |
| K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021-01-29 | Traditional | PDF ↗ |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018-08-02 | Traditional | PDF ↗ |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | 2017-09-14 | Traditional | PDF ↗ |
| K153234 | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | 2016-07-07 | Traditional | PDF ↗ |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | 2016-06-23 | Traditional | PDF ↗ |
| K151461 | Hybernite RT | Plastiflex Group NV | 2016-03-24 | Traditional | PDF ↗ |
| K151303 | AirLife Infant Heated Wire Circuit | Care Fusion | 2016-01-21 | Traditional | PDF ↗ |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | 2016-01-20 | Traditional | PDF ↗ |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | 2015-05-15 | Traditional | PDF ↗ |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | 2014-11-14 | Traditional | PDF ↗ |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 | Traditional | PDF ↗ |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 | Traditional | PDF ↗ |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | 2011-06-01 | Abbreviated | PDF ↗ |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | Intersurgical, Inc. | 2010-05-18 | Traditional | PDF ↗ |
| K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | Plastiflex Group NV | 2010-04-14 | Traditional | PDF ↗ |
| K034026 | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 | Traditional | PDF ↗ |
| K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | Allegiance Healthcare Corp. | 2000-03-30 | Special | PDF ↗ |
| K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | Allegiance Healthcare Corp. | 1999-12-10 | Special | PDF ↗ |
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Nova-Ventrx | 1997-12-02 | Traditional | PDF ↗ |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | Marquest Medical Products, Inc. | 1997-01-14 | Traditional | PDF ↗ |
| K914994 | HPD HEATER BASES | Hpd Medical, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | Baxter Healthcare Corp | 1993-01-12 | Traditional | PDF ↗ |
| K894654 | FLEXHTR-1 | Bird Products Corp. | 1990-08-01 | Traditional | PDF ↗ |
| K894936 | PROTOLOGIC MODEL SER-1 | Protologic, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Dryden Corp. | 1988-08-24 | Traditional | PDF ↗ |
| K881231 | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT | Intertech Resources, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | Respiratory Care, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE | Simplex Medical Corp. | 1988-06-10 | Traditional | PDF ↗ |
| K881137 | VAPOR-PHASE HEATED WIRE CONTROLLER | Advanced Research Technologies, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Life Design Systems, Inc. | 1988-03-31 | Traditional | PDF ↗ |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | Intec Medical, Inc. | 1986-04-02 | Traditional | PDF ↗ |
| K851245 | ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY | Applinc | 1985-05-15 | Traditional | PDF ↗ |
| K842597 | RESPIRATORY GAS HUMIDIFIER | Applinc | 1985-01-16 | Traditional | PDF ↗ |
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | Armour Pharmaceutical Co. | 1984-11-08 | Traditional | PDF ↗ |
| K821735 | TROPIC AIR HEAT-ECHANGER BREATHING AID | Tropic Air | 1982-09-07 | Traditional | PDF ↗ |
| K801101 | ANALOR FOUR-ORAL SURGERY MODEL | Narco Mckesson Co. | 1980-06-17 | Traditional | PDF ↗ |
| K781530 | TEMPERATURE CONTROLLER MODEL 17000 | Healthdyne, Inc. | 1978-11-14 | Traditional | PDF ↗ |
| K780630 | CONTROLLER, SERVO, INSPIRON | C.R. Bard, Inc. | 1978-05-31 | Traditional | PDF ↗ |
| K770984 | TA-2 TEMPERATURE ALARM | Mistogen Equipment Co. | 1977-07-05 | Traditional | PDF ↗ |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | Harris-Lake, Inc. | 1976-12-30 | Traditional | PDF ↗ |
Product code BZE · Class II · Anesthesiology. Data: openFDA.