Humidifier, Respiratory Gas, (direct Patient Interface)

Device Code: 26

Product Code(s): BTT

Device Classification Information

• Device Type ID: 26
• Device Name: Humidifier, Respiratory Gas, (direct Patient Interface)
• Regulation Description: Respiratory Gas Humidifier.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BTT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 1-62 ISO 5356-1 Third Edition 2004-05-15
  Anaesthetic And Respiratory Equipment - Conical Connectors: Part 1: Cones And Sockets
• 1-134 ISO 18562-1 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
• 1-135 ISO 18562-2 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
• 1-137 ISO 18562-4 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate
• 1-138 ISO 80601-2-74 First Edition 2017-05
  Medical Electrical Equipment - Part 2-74: Particular Requirements For Basic Safety And Essential Performance Of Respiratory Humidifying Equipment

Total Product Life Cycle

• Device Type ID: 26
• Device: Humidifier, Respiratory Gas, (direct Patient Interface)
• Product Code: BTT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Respiratory Gas Humidifier.
• CFR Regulation Number: 868.5450 [🔎]

Premarket Reviews
Manufacturer	Decision
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
FISHER & PAYKEL HEALTHCARE NZ LTD
	SUBSTANTIALLY EQUIVALENT	1
GRUENDLER GMBH
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON
	SUBSTANTIALLY EQUIVALENT	2
HAMILTON MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	2
PACIFIC MEDICO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
TELEFLEX MEDICAL , INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
No Audible Alarm	2066
Power Problem	226
Failure To Power Up	185
Leak / Splash	175
Connection Problem	168
Crack	160
Device Operates Differently Than Expected	151
Temperature Problem	127
Device Alarm System	95
Insufficient Heating	87
Overheating Of Device	50
Device Issue	46
Device Handling Problem	26
Device Stops Intermittently	23
Adverse Event Without Identified Device Or Use Problem	21
No Flow	19
Device Sensing Problem	19
No Display / Image	17
Melted	17
Hole In Material	17
Fitting Problem	16
False Alarm	15
Break	14
Fluid Leak	13
Insufficient Information	13
Disconnection	13
Air Leak	13
Moisture Or Humidity Problem	12
Protective Measures Problem	11
Failure Of Device To Self-Test	11
Failure To Deliver	11
Appropriate Term/Code Not Available	10
Kinked	10
Detachment Of Device Or Device Component	10
Overfill	9
Loss Of Or Failure To Bond	7
Failure To Sense	7
Restricted Flow Rate	7
Pressure Problem	7
Detachment Of Device Component	6
Device Emits Odor	6
Cut In Material	6
Tear, Rip Or Hole In Device Packaging	6
No Apparent Adverse Event	6
Use Of Device Problem	5
Device Displays Incorrect Message	4
Filling Problem	4
Loose Or Intermittent Connection	4
Breathing Circuit	4
Partial Blockage	3
Defective Alarm	3
Thermal Decomposition Of Device	3
No Device Output	3
Torn Material	3
Noise, Audible	3
Occlusion Within Device	3
Difficult To Open Or Close	3
Physical Property Issue	3
Obstruction Of Flow	3
Device Operational Issue	3
Infusion Or Flow Problem	3
Human-Device Interface Problem	2
Bent	2
Burst Container Or Vessel	2
Fire	2
Material Integrity Problem	2
Material Discolored	2
Improper Or Incorrect Procedure Or Method	2
Delivered As Unsterile Product	2
Circuit Failure	2
Electrical /Electronic Property Problem	2
Failure To Reset	2
Improper Flow Or Infusion	2
Failure To Align	2
Split	2
Device Slipped	2
Display Or Visual Feedback Problem	2
Material Separation	2
Folded	1
Computer Operating System Problem	1
Flowmeter	1
Loss Of Power	1
Unexpected Shutdown	1
Power Cord	1
Decrease In Pressure	1
Reflux Within Device	1
Device Contamination With Chemical Or Other Material	1
Improper Alarm	1
Device Contaminated During Manufacture Or Shipping	1
Material Deformation	1
Inaudible Or Unclear Audible Prompt / Feedback	1
Electrical Shorting	1
Mechanical Problem	1
Connection Error	1
Adapter (Adaptor)	1
Probe	1
Stretched	1
Microbial Contamination Of Device	1
Inaccurate Delivery	1
Housing	1
Total Device Problems	4047

Recalls
Manufacturer		Recall Class	Date Posted
1	Teleflex Medical	II	Dec-15-2015
2	Teleflex Medical	II	Apr-30-2015
3	Teleflex Medical	II	Feb-12-2015
4	Teleflex Medical	II	Jul-23-2014
5	Teleflex Medical	II	Jul-07-2014
6	Vapotherm, Inc.	II	Sep-25-2014
7	Vyaire Medical	I	Jan-24-2018

TPLC Last Update: 2019-04-02 19:27:03