Generator, Oxygen, Portable

Device Code: 92

Product Code(s): CAW

Device Classification Information

• Device Type ID: 92
• Device Name: Generator, Oxygen, Portable
• Regulation Description: Portable Oxygen Generator.
• 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); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5440 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CAW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 1-102 ISO 80601-2-69 First Edition 2014-07-15
  Medical Electrical Equipment - Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment
• 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
• 1-136 ISO 18562-3 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
• 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

Total Product Life Cycle

• Device Type ID: 92
• Device: Generator, Oxygen, Portable
• Product Code: CAW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Portable Oxygen Generator.
• CFR Regulation Number: 868.5440 [🔎]

Premarket Reviews
Manufacturer	Decision
AIRSEP CORP.
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ESSEX CRYOGENICS OF MISSOURI, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOVA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOVO, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LONGFIAN SCITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMTC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Alarm System	185
Adverse Event Without Identified Device Or Use Problem	79
Fire	59
Break	56
Device Operates Differently Than Expected	52
Loss Of Power	43
Display	42
Device Operational Issue	40
Device Displays Incorrect Message	23
No Audible Alarm	22
Improper Or Incorrect Procedure Or Method	20
Thermal Decomposition Of Device	18
Use Of Device Problem	17
Failure To Power Up	14
Concentrator	13
Device Emits Odor	13
Insufficient Information	13
Gas Output Problem	13
Device Inoperable	13
Electrical /Electronic Property Problem	12
Overheating Of Device	10
Power Switch	9
Mechanical Problem	9
Noise, Audible	9
Defective Alarm	8
Battery Problem	8
Screen	7
Melted	6
PC (Printed Circuit) Board	6
Sparking	5
Contamination During Use	5
Smoking	5
Insufficient Flow Or Under Infusion	5
Improper Flow Or Infusion	5
Environmental Particulates	5
Unexpected Shutdown	4
Leak / Splash	4
Defective Device	4
Output Problem	4
Switch, Push Button	4
Failure To Charge	4
No Display / Image	4
Failure To Deliver	4
Appropriate Term/Code Not Available	4
Infusion Or Flow Problem	4
Power Problem	3
Wire	3
Connection Problem	3
Loose Or Intermittent Connection	3
Filter	3
Cut In Material	2
Diode	2
Power Cord	2
Electrical Shorting	2
Sticking	2
Detachment Of Device Component	2
Device Issue	2
Compressor (Air Pump)	2
Off-Label Use	2
Unit	2
No Flow	2
No Apparent Adverse Event	2
Cord	2
Component Missing	2
Improper Device Output	2
Product Quality Problem	2
Device Stops Intermittently	1
Defective Component	1
Material Discolored	1
Battery	1
Circuit Board	1
Valve	1
Issue With Displayed Error Message	1
Medical Gas Supply Problem	1
Charging Problem	1
Programming Issue	1
Function Indicator Light	1
Unintended Electrical Shock	1
Communication Or Transmission Problem	1
False Reading From Device Non-Compliance	1
Failure To Sense	1
Gas Leak	1
Human-Device Interface Problem	1
Manifold	1
Activation, Positioning Or Separation Problem	1
Inadequate Lighting	1
Maintenance Does Not Comply To Manufacturers Recommendations	1
Explosion	1
Extrusion	1
Output Below Specifications	1
Function Indicator	1
Premature Discharge Of Battery	1
Circuit Failure	1
Self-Activation Or Keying	1
Inadequate Service	1
Invalid Sensing	1
Out-Of-Box Failure	1
Alarm, LED	1
Spring	1
Separation Failure	1
Total Device Problems	970

Recalls
Manufacturer		Recall Class	Date Posted
1	Inovo, Inc	II	Jan-24-2018
2	Inovo, Inc	II	Dec-14-2016
3	Invacare Corporation	II	Dec-24-2014
4	Invacare Corporation	II	Dec-12-2014
5	On Site Gas Systems Inc.	II	Jan-08-2014
6	Oxysure Systems, Inc.	II	Jul-24-2015

TPLC Last Update: 2019-04-02 19:28:50