Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits

FDA has not posted a summary or statement for it, so its predicates are not known.

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

• K151303AirLife Infant Heated Wire CircuitCare Fusion · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
• K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
• K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
• K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
• K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
• K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
• K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
• K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
• K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
• K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
• K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
• K153046Hamilton-MR1Hamilton Medical AG · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 12 of 21 shown.

Nearest 5 of 21; all are on the web page.

What does this lineage say?

• Of its descendants, K020332 (Fisher & Paykel Healthcare, Ltd., 2003) has gone furthest, with 65 descendants of its own.

BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer: FDA decisions, review times, recalls and adverse event reports over 20 years.