AQUAPAK 020 HUMIDIFIER ADAPTER— 510(k) K833974

Clearance details

Applicant

Respiratory Care, Inc.

Product code

Code BTT

Device class

Class 2

Regulation

21 CFR 868.5450

Advisory panel

Anesthesiology

Date received

1983-11-16

Decision date

1983-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K262268 — Optiflow Oxygen Kit (AA484J)2026-08-27
• K254078 — HVT 2.02026-04-13
• K251448 — FL-10000U Respiratory Humidifier2026-01-16
• K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP2026-01-14
• K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)2025-12-19

• K892230 — RCI VIRAL/BACTERIAL FILTER1989-08-28
• K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER1988-11-21
• K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL1988-06-21
• K864147 — AQUAVALVE1986-12-05
• K863955 — COLBY LEVEL ALARM1986-11-07

Death

60

Injury

152

Malfunction

7,232

Other

2

Total

7,446

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1095-2015 — Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1096-2015 — AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1097-2015 — AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1098-2015 — AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1099-2015 — AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1100-2015 — AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1101-2015 — AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1102-2015 — AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1103-2015 — AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1104-2015 — AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1105-2015 — AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1106-2015 — AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1107-2015 — ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1108-2015 — AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-1109-2015 — AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.Class II·Terminated·Teleflex Medical·20150114
• Z-2003-2014 — Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .Class II·Terminated·Teleflex Medical·20140605
• Z-2004-2014 — Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .Class II·Terminated·Teleflex Medical·20140605
• Z-2005-2014 — Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptorClass II·Terminated·Teleflex Medical·20140605
• Z-2006-2014 — Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.Class II·Terminated·Teleflex Medical·20140605
• Z-2007-2014 — Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.Class II·Terminated·Teleflex Medical·20140605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833974.