FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K993833 |
ALLEGIANCE HEALTHCARE CORP. |
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS |
12/10/1999 |
K000697 |
ALLEGIANCE HEALTHCARE CORP. |
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS |
03/30/2000 |
K151303 |
CAREFUSION |
AirLife Infant Heated Wire Circuit |
01/21/2016 |
K153234 |
CAREFUSION INC |
AirLife Adult Heated Wire Circuit |
07/07/2016 |
K151959 |
CAREFUSION INC |
AirLife Infant Single Limb Heated Wire Circuit |
01/20/2016 |
K222822 |
Draegerwerk AG & Co. KGaA |
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) |
06/14/2023 |
K103767 |
FISHER & PAYKEL HEALTHCARE LTD. |
DUAL HEATED INFANT VREATHING CIROUITS |
04/16/2012 |
K122432 |
FISHER & PAYKEL HEALTHCARE, LTD. |
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS |
12/06/2012 |
K034026 |
FISHER & PAYKEL HEALTHCARE, LTD. |
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS |
01/12/2005 |
K160540 |
FLEXICARE MEDICAL LIMITED |
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM |
06/23/2016 |
K150900 |
FLEXICARE MEDICAL LTD. |
Flexicare Heated Wire Breathing Systems |
05/15/2015 |
K092129 |
INTERSURGICAL, INC. |
INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 |
05/18/2010 |
K962220 |
MARQUEST MEDICAL PRODUCTS, INC. |
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER |
01/14/1997 |
K952267 |
NOVA-VENTRX |
CRITERION, CRITERION I.V., MODIFIED |
12/02/1997 |
K100104 |
PLASTIFLEX GROUP NV |
HYBERNITE RAINOUT CONTROL SYSTEM |
04/14/2010 |
K151461 |
PLASTIFLEX GROUP NV |
Hybernite RT |
03/24/2016 |
K110398 |
RESPIRONICS, INC. |
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS |
06/01/2011 |
K140424 |
RESPIRONICS, INC. |
RESPIRONICS REUSABLE HEATED TUBING |
11/14/2014 |
K201418 |
Sunset Healthcare Solutions, Inc. |
Sunset Heated CPAP Tube |
01/29/2021 |
K173280 |
Teleflex Medical, Inc |
Neonatal ConchaSmart Breathing Circuits |
08/02/2018 |
K170378 |
Vyaire Medical |
AirLife Adult Heated Wire BiPAP/NIV Circuit |
09/14/2017 |