Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Device Code: 114

Product Code(s): CCK

Device Classification Information

• Device Type ID: 114
• Device Name: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Regulation Description: Carbon Dioxide Gas Analyzer.
• 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: 868.1400 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CCK
• 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

• 1-96 ISO 80601-2-55 First Edition 2011-12-15
  Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors
• 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
• 1-140 ISO 80601-2-55 Second Edition 2018-02
  Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors

Total Product Life Cycle

• Device Type ID: 114
• Device: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Product Code: CCK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Carbon Dioxide Gas Analyzer.
• CFR Regulation Number: 868.1400 [🔎]

Premarket Reviews
Manufacturer	Decision
ABEON MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BESMED HEALTH BUSINESS CORP.
	SUBSTANTIALLY EQUIVALENT	1
CIEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CMI HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
DISPO-MED (MALAYSIA) SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	2
MAXTEC
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	4
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
POM MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	1
SOUTHMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VENTURE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
WESTMED HOLDING CO.
	SUBSTANTIALLY EQUIVALENT	1
WESTMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Displays Incorrect Message	66
Device Inoperable	35
Device Operates Differently Than Expected	30
Device Stops Intermittently	24
Output Problem	21
Incorrect, Inadequate Or Imprecise Result Or Readings	19
Failure To Calibrate	14
Incorrect Measurement	9
Smoking	8
No Audible Alarm	8
Device Sensing Problem	7
Failure To Sense	7
Calibration Problem	6
Unable To Obtain Readings	6
Device Issue	5
Device Operational Issue	5
Failure To Deliver	5
Invalid Sensing	5
Material Integrity Problem	4
Low Readings	3
Display Difficult To Read	3
Battery	3
Sparking	3
Monitor	3
Partial Blockage	2
Device Emits Odor	2
Failure To Power Up	2
Calibration Error	2
Disconnection	2
Overheating Of Device	2
Display Or Visual Feedback Problem	2
Mechanical Problem	2
Human-Device Interface Problem	2
Power Problem	2
Adverse Event Without Identified Device Or Use Problem	2
Wire	2
Screen	2
Electrical /Electronic Property Problem	2
Occlusion Within Device	2
Use Of Device Problem	2
Degraded	1
No Display / Image	1
Gas Output Problem	1
Device Difficult To Program Or Calibrate	1
Misassembled	1
Intermittent Continuity	1
Gauges/Meters	1
O2 Monitor Subassembly (Only Use When Part Of Another Device)	1
CO2 Monitor	1
High Readings	1
Inappropriate Or Unexpected Reset	1
False Alarm	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1
Electronic Property Issue	1
False Reading From Device Non-Compliance	1
Migration Or Expulsion Of Device	1
No Device Output	1
Labelling, Instructions For Use Or Training Problem	1
Break	1
Detachment Of Device Or Device Component	1
Insufficient Information	1
Restricted Flow Rate	1
Loose Or Intermittent Connection	1
Low Sensing Threshold	1
Sensor	1
Device Alarm System	1
Incorrect Interpretation Of Signal	1
Out-Of-Box Failure	1
Gas Delivery System	1
Intermittent Loss Of Power	1
Unexpected Shutdown	1
False Negative Result	1
Material Fragmentation	1
Fitting Problem	1
Low Test Results	1
Total Device Problems	366

Recalls
Manufacturer		Recall Class	Date Posted
1	CareFusion 303, Inc.	II	Dec-21-2015
2	GE Healthcare, LLC	I	Jul-18-2014
3	Medtronic	I	May-12-2016
4	Oridion Medical 1987 Ltd.	II	Oct-03-2018
5	Smiths Medical ASD Inc.	II	Jul-06-2018
6	Smiths Medical ASD, Inc.	II	May-29-2015
7	Southmedic, Inc.	II	Jan-25-2018
8	Ventlab LLC	II	Jun-01-2016

TPLC Last Update: 2019-04-02 19:29:14