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TPLC
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Device
analyzer, gas, carbon-dioxide, gaseous-phase
Product Code
CCK
Regulation Number
868.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
BLUEPOINT MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
1. K220533
Endoscopy Oxygen Mask
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
3
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIPINES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POM MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
RESPIRION, INC.
SUBSTANTIALLY EQUIVALENT
1
REVOLUTIONARY MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VENTURE THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
58
58
2018
63
63
2019
141
141
2020
2306
2306
2021
2272
2272
2022
2476
2476
2023
83
83
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2116
2116
Communication or Transmission Problem
1569
1569
Crack
1440
1440
Appropriate Term/Code Not Available
940
940
Corroded
684
684
Failure to Calibrate
672
672
Incorrect, Inadequate or Imprecise Result or Readings
565
565
Contamination
486
486
Device Alarm System
457
457
Failure of Device to Self-Test
451
451
No Device Output
390
390
No Apparent Adverse Event
382
382
Computer Software Problem
342
342
Insufficient Information
274
274
Circuit Failure
271
271
Calibration Problem
251
251
Loose or Intermittent Connection
220
220
Output Problem
204
204
Device Sensing Problem
183
183
Failure to Read Input Signal
104
104
Physical Resistance/Sticking
79
79
Display or Visual Feedback Problem
70
70
Display Difficult to Read
58
58
Application Program Freezes, Becomes Nonfunctional
57
57
Misassembled
49
49
Unable to Obtain Readings
44
44
Incorrect Measurement
38
38
Pumping Stopped
36
36
Failure to Power Up
35
35
Peeled/Delaminated
33
33
Naturally Worn
26
26
Degraded
25
25
Application Program Problem
25
25
Failure to Cycle
25
25
High Readings
24
24
Low Readings
23
23
Electrical /Electronic Property Problem
21
21
Power Problem
20
20
Gas Output Problem
18
18
Temperature Problem
16
16
Device Operates Differently Than Expected
16
16
Image Display Error/Artifact
15
15
Mechanical Problem
13
13
Device Displays Incorrect Message
13
13
No Audible Alarm
12
12
Device Markings/Labelling Problem
11
11
Erratic or Intermittent Display
11
11
Use of Device Problem
10
10
Defective Device
10
10
Noise, Audible
10
10
False Alarm
10
10
Device Stops Intermittently
10
10
No Display/Image
9
9
Mechanics Altered
8
8
Failure to Sense
8
8
Application Program Version or Upgrade Problem
7
7
Unexpected Shutdown
7
7
Battery Problem
7
7
Defective Alarm
7
7
Obstruction of Flow
7
7
Failure to Deliver
7
7
Component Missing
6
6
Smoking
6
6
Defective Component
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Device Inoperable
6
6
Partial Blockage
5
5
Charging Problem
5
5
Inaccurate Information
5
5
Device Operational Issue
5
5
Device Issue
5
5
Device Damaged Prior to Use
5
5
Invalid Sensing
5
5
Electrical Power Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Filtration Problem
4
4
Nonstandard Device
4
4
Infusion or Flow Problem
4
4
Intermittent Loss of Power
4
4
Protective Measures Problem
4
4
Device Ingredient or Reagent Problem
4
4
Data Problem
4
4
Sensing Intermittently
4
4
Pressure Problem
3
3
Computer Operating System Problem
3
3
Gas/Air Leak
3
3
Human-Device Interface Problem
3
3
Sparking
3
3
Material Fragmentation
3
3
Device Emits Odor
3
3
Overheating of Device
3
3
Component Misassembled
3
3
Intermittent Communication Failure
3
3
Inappropriate or Unexpected Reset
3
3
Moisture or Humidity Problem
3
3
No Audible Prompt/Feedback
3
3
Failure to Analyze Signal
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4157
4157
No Patient Involvement
3003
3003
No Known Impact Or Consequence To Patient
147
147
No Consequences Or Impact To Patient
143
143
No Information
88
88
Insufficient Information
81
81
Cardiac Arrest
3
3
Low Oxygen Saturation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Foreign Body In Patient
2
2
Death
2
2
Hypoxia
2
2
Unspecified Tissue Injury
2
2
Respiratory Distress
2
2
Injury
1
1
Burn, Thermal
1
1
Chest Pain
1
1
Laceration(s)
1
1
Pain
1
1
Pressure Sores
1
1
Lethargy
1
1
Superficial (First Degree) Burn
1
1
Partial thickness (Second Degree) Burn
1
1
Unintended Extubation
1
1
Cardiopulmonary Arrest
1
1
Perforation
1
1
Inadequate Pain Relief
1
1
Death, Intrauterine Fetal
1
1
Patient Problem/Medical Problem
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Cyanosis
1
1
Hypersensitivity/Allergic reaction
1
1
Extubate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Aug-30-2019
2
Covidien Llc
II
Dec-01-2020
3
GE Healthcare, LLC
I
Jan-10-2020
4
Oridion Medical 1987 Ltd.
II
Oct-03-2018
5
Smiths Medical ASD Inc.
II
Jul-06-2018
6
Southmedic, Inc.
II
Jul-24-2021
7
Southmedic, Inc.
II
Jan-25-2018
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