Atlas FDA

AQUAPAK 020 HUMIDIFIER ADAPTER

FDA 510(k) clearance K833974 · decided 1983-12-16

Clearance details

K-number
K833974
Device name
AQUAPAK 020 HUMIDIFIER ADAPTER
Applicant
Respiratory Care, Inc.
Decision
Substantially Equivalent
Date received
1983-11-16
Decision date
1983-12-16
Days to decision
30 days
Clearance type
Traditional
Product code
BTT
Device class
2
Regulation number
868.5450
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 04 recall (Z-1095-2015)Teleflex Medical2015-02-12
AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an acce recall (Z-1096-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessor recall (Z-1097-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an acc recall (Z-1098-2015)Teleflex Medical2015-02-12
AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an acces recall (Z-1099-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an ac recall (Z-1100-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an recall (Z-1101-2015)Teleflex Medical2015-02-12
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory whic recall (Z-1102-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory recall (Z-1103-2015)Teleflex Medical2015-02-12
AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an acce recall (Z-1104-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an acc recall (Z-1105-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an acc recall (Z-1106-2015)Teleflex Medical2015-02-12
ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows recall (Z-1107-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an acc recall (Z-1108-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an acc recall (Z-1109-2015)Teleflex Medical2015-02-12
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas hu recall (Z-2003-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas hu recall (Z-2004-2014)Teleflex Medical2014-07-07
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2005-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adapto recall (Z-2006-2014)Teleflex Medical2014-07-07
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier a recall (Z-2007-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifie recall (Z-2008-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2009-2014)Teleflex Medical2014-07-07
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2010-2014)Teleflex Medical2014-07-07
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier ada recall (Z-2011-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor recall (Z-2012-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier recall (Z-2013-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2014-2014)Teleflex Medical2014-07-07
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2015-2014)Teleflex Medical2014-07-07
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2016-2014)Teleflex Medical2014-07-07
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier ad recall (Z-2017-2014)Teleflex Medical2014-07-07