ClearanceBrief
Panels › Anesthesiology › Product code BTT · Class 2

Humidifier, Respiratory Gas, (Direct Patient Interface)

Regulation 868.5450

5510(k)s in 12 months (222 all time)
1recalls in 12 months (70 all time)
66recalls that name a 510(k)
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Top companies in BTT

DateFirm and productCodeLinked 510(k)
Jul 7, 2014Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Terminated
BTTK833974
Jul 7, 2014Teleflex Medical
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Terminated
BTTK833974
Jul 7, 2014Teleflex Medical
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Terminated
BTTK833974
Jul 7, 2014Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Terminated
BTTK833974
Jul 19, 2012Teleflex Medical
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Terminated
BTTK063758
Jul 12, 2011Teleflex Medical
HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water vapor to a dry medical gas for administration to a patient.
Terminated
BTTK993355
Aug 13, 2010Teleflex Medical
Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passiv
Terminated
BTTNone listed
Mar 9, 2010Telefelx Medical
Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
Terminated
BTTK063758
Dec 10, 2008Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patien
Terminated
BTTK983112
Jun 20, 2007Porous Media Corporation
HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
Terminated
BTTK062091
Jan 10, 2007Respironics, Inc.
REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265
Terminated
BTTK010263
Jan 10, 2007Respironics, Inc.
REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
Terminated
BTTK010263
Mar 29, 2006Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
Terminated
BTTK983112
Mar 29, 2006Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
Terminated
BTTK983112
Mar 29, 2006Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
Terminated
BTTK983112
Mar 29, 2006Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110
Terminated
BTTK983112
Feb 8, 2006Teleflex Medical
AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA
Terminated
BTTNone listed
Jan 19, 2006Vapotherm, Inc.
Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
Terminated
BTTNone listed
Feb 18, 2005Fisher & Paykel Healthcare Inc
RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
Terminated
BTTK020332
Jul 20, 2004Hudson Respiratory Care Inc
Concha IV Plus Heated Humidifier
Terminated
BTTNone listed

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