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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
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
2
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
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K210112
XChange Device, XChange System
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1638
1638
2024
827
827
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3302
3302
Communication or Transmission Problem
2461
2461
Crack
2292
2292
Appropriate Term/Code Not Available
944
944
Corroded
938
938
Failure to Calibrate
862
862
Incorrect, Inadequate or Imprecise Result or Readings
720
720
Device Alarm System
604
604
Computer Software Problem
564
564
Contamination
517
517
Failure of Device to Self-Test
474
474
No Device Output
464
464
No Apparent Adverse Event
411
411
Loose or Intermittent Connection
405
405
Calibration Problem
357
357
Circuit Failure
300
300
Insufficient Information
294
294
Output Problem
204
204
Device Sensing Problem
176
176
Physical Resistance/Sticking
116
116
Failure to Read Input Signal
109
109
Display Difficult to Read
76
76
Display or Visual Feedback Problem
72
72
Application Program Freezes, Becomes Nonfunctional
62
62
Unable to Obtain Readings
50
50
Misassembled
48
48
Incorrect Measurement
37
37
Failure to Power Up
37
37
Peeled/Delaminated
37
37
Pumping Stopped
37
37
High Readings
33
33
Low Readings
31
31
Missing Information
29
29
Degraded
27
27
Naturally Worn
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
23
23
Power Problem
22
22
Gas Output Problem
19
19
Image Display Error/Artifact
18
18
Temperature Problem
17
17
Device Markings/Labelling Problem
15
15
Mechanical Problem
15
15
No Display/Image
15
15
Erratic or Intermittent Display
14
14
Noise, Audible
12
12
False Alarm
12
12
Unexpected Shutdown
12
12
Defective Device
10
10
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6496
6496
No Patient Involvement
2984
2984
No Consequences Or Impact To Patient
117
117
Insufficient Information
114
114
No Information
81
81
No Known Impact Or Consequence To Patient
76
76
Unintended Extubation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unspecified Tissue Injury
4
4
Cardiac Arrest
3
3
Death
2
2
Foreign Body In Patient
2
2
Hypoxia
2
2
Cyanosis
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoventilation
1
1
Respiratory Arrest
1
1
Chest Pain
1
1
Discomfort
1
1
Cardiopulmonary Arrest
1
1
Laceration(s)
1
1
Pain
1
1
Anxiety
1
1
Cough
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Low Oxygen Saturation
1
1
Lethargy
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
Southmedic, Inc.
II
Jul-24-2021
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