Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZE — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
176 daysmedian FDA review time
380 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heat | Vincent Healthcare Products Limited | 2026-06-18 | 352 | 0 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / | Medline Industries, LP | 2026-03-25 | 176 | 0 |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025-07-25 | 287 | 0 |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024-08-02 | 88 | 0 |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Ad | Medline Industries, LP | 2024-06-04 | 167 | 0 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Heli | Draegerwerk AG & CO Kgaa | 2023-06-14 | 268 | 0 |
| K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021-01-29 | 245 | 0 |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018-08-02 | 290 | 1 |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | 2017-09-14 | 219 | 0 |
| K153234 | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | 2016-07-07 | 241 | 0 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | 2016-06-23 | 118 | 0 |
| K151461 | Hybernite RT | Plastiflex Group NV | 2016-03-24 | 297 | 0 |
| K151303 | AirLife Infant Heated Wire Circuit | Care Fusion | 2016-01-21 | 248 | 2 |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | 2016-01-20 | 188 | 0 |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | 2015-05-15 | 42 | 0 |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | 2014-11-14 | 268 | 0 |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 | 118 | 0 |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 | 480 | 0 |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | 2011-06-01 | 110 | 0 |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATI | Intersurgical, Inc. | 2010-05-18 | 307 | 0 |
| K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | Plastiflex Group NV | 2010-04-14 | 91 | 0 |
| K034026 | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 | 380 | 0 |
| K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BRE | Allegiance Healthcare Corp. | 2000-03-30 | 29 | 0 |
| K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | Allegiance Healthcare Corp. | 1999-12-10 | 28 | 0 |
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Nova-Ventrx | 1997-12-02 | 932 | 0 |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | Marquest Medical Products, Inc. | 1997-01-14 | 218 | 0 |
| K914994 | HPD HEATER BASES | Hpd Medical, Inc. | 1993-02-12 | 463 | 0 |
| K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | Baxter Healthcare Corp | 1993-01-12 | 419 | 4 |
| K894654 | FLEXHTR-1 | Bird Products Corp. | 1990-08-01 | 373 | 0 |
| K894936 | PROTOLOGIC MODEL SER-1 | Protologic, Inc. | 1990-01-22 | 172 | 0 |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Dryden Corp. | 1988-08-24 | 177 | 0 |
| K881231 | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT | Intertech Resources, Inc. | 1988-07-01 | 101 | 0 |
| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | Respiratory Care, Inc. | 1988-06-21 | 70 | 0 |
| K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE | Simplex Medical Corp. | 1988-06-10 | 65 | 0 |
| K881137 | VAPOR-PHASE HEATED WIRE CONTROLLER | Advanced Research Technologies, Inc. | 1988-04-27 | 42 | 0 |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Life Design Systems, Inc. | 1988-03-31 | 232 | 0 |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | Intec Medical, Inc. | 1986-04-02 | 21 | 0 |
| K851245 | ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY | Applinc | 1985-05-15 | 49 | 0 |
| K842597 | RESPIRATORY GAS HUMIDIFIER | Applinc | 1985-01-16 | 197 | 0 |
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | Armour Pharmaceutical Co. | 1984-11-08 | 27 | 0 |
| K821735 | TROPIC AIR HEAT-ECHANGER BREATHING AID | Tropic Air | 1982-09-07 | 85 | 0 |
| K801101 | ANALOR FOUR-ORAL SURGERY MODEL | Narco Mckesson Co. | 1980-06-17 | 39 | 0 |
| K781530 | TEMPERATURE CONTROLLER MODEL 17000 | Healthdyne, Inc. | 1978-11-14 | 69 | 0 |
| K780630 | CONTROLLER, SERVO, INSPIRON | C.R. Bard, Inc. | 1978-05-31 | 44 | 0 |
| K770984 | TA-2 TEMPERATURE ALARM | Mistogen Equipment Co. | 1977-07-05 | 35 | 0 |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | Harris-Lake, Inc. | 1976-12-30 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda