Humidifier, Non-direct Patient Interface (home-use)

Device Code: 137

Product Code(s): KFZ

Device Classification Information

• Device Type ID: 137
• Device Name: Humidifier, Non-direct Patient Interface (home-use)
• Regulation Description: Therapeutic Humidifier For Home Use.
• 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) Exempt
• CFR Regulation Number: 868.5460 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KFZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 137
• Device: Humidifier, Non-direct Patient Interface (home-use)
• Product Code: KFZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Therapeutic Humidifier For Home Use.
• CFR Regulation Number: 868.5460 [🔎]

Device Problems
Humidifier	27
Adverse Event Without Identified Device Or Use Problem	22
Improper Or Incorrect Procedure Or Method	10
Fire	7
Use Of Device Problem	4
Smoking	3
Melted	2
Thermal Decomposition Of Device	2
Device Damaged Prior To Use	1
Thermometer	1
Device Handling Problem	1
Sparking	1
Human-Device Interface Problem	1
Total Device Problems	82

Recalls
Manufacturer		Recall Class	Date Posted
1	Bigwall Enterprises	II	Feb-25-2016

TPLC Last Update: 2019-04-02 19:29:34