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TPLC
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show TPLC since
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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
1. K213518
CARESCAPE CO2 Microstream parameter
2. K213911
Microstream CO2 NanoPod
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
1. K213518
CARESCAPE CO2 Microstream parameter
2. K213911
Microstream CO2 NanoPod
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
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POM MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
RESPIRION, INC.
SUBSTANTIALLY EQUIVALENT
1
REVOLUTIONARY MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
63
63
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1638
1638
2024
1089
1089
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3344
3344
Communication or Transmission Problem
2591
2591
Crack
2335
2335
Corroded
978
978
Appropriate Term/Code Not Available
944
944
Failure to Calibrate
897
897
Incorrect, Inadequate or Imprecise Result or Readings
733
733
Device Alarm System
629
629
Computer Software Problem
564
564
Contamination
527
527
Failure of Device to Self-Test
478
478
No Device Output
467
467
Loose or Intermittent Connection
417
417
No Apparent Adverse Event
413
413
Calibration Problem
379
379
Circuit Failure
300
300
Insufficient Information
295
295
Output Problem
218
218
Device Sensing Problem
180
180
Physical Resistance/Sticking
119
119
Failure to Read Input Signal
109
109
Display Difficult to Read
77
77
Display or Visual Feedback Problem
74
74
Application Program Freezes, Becomes Nonfunctional
62
62
Unable to Obtain Readings
57
57
Incorrect Measurement
55
55
Misassembled
49
49
Low Readings
45
45
High Readings
40
40
Failure to Power Up
39
39
Peeled/Delaminated
38
38
Pumping Stopped
37
37
Missing Information
31
31
Naturally Worn
28
28
Degraded
28
28
Application Program Problem
27
27
Failure to Cycle
25
25
Electrical /Electronic Property Problem
24
24
Power Problem
22
22
Gas Output Problem
20
20
Temperature Problem
20
20
Image Display Error/Artifact
19
19
Mechanical Problem
18
18
No Display/Image
17
17
Device Markings/Labelling Problem
15
15
Erratic or Intermittent Display
14
14
Noise, Audible
13
13
Unexpected Shutdown
13
13
False Alarm
12
12
Use of Device Problem
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6751
6751
No Patient Involvement
2990
2990
No Consequences Or Impact To Patient
132
132
Insufficient Information
122
122
No Known Impact Or Consequence To Patient
114
114
No Information
81
81
Unintended Extubation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Cardiac Arrest
4
4
Unspecified Tissue Injury
4
4
Foreign Body In Patient
3
3
Low Oxygen Saturation
3
3
Death
2
2
Respiratory Distress
2
2
Pain
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
Perforation
1
1
Injury
1
1
Chest Pain
1
1
Discomfort
1
1
Cardiopulmonary Arrest
1
1
Laceration(s)
1
1
Anxiety
1
1
Cough
1
1
Pressure Sores
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Bruise/Contusion
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
Nihon Kohden America Inc
II
Nov-06-2024
5
Oridion Medical 1987 Ltd.
II
Oct-03-2018
6
Smiths Medical ASD Inc.
II
Jul-06-2018
7
Southmedic, Inc.
II
Jul-24-2021
8
Southmedic, Inc.
II
Jan-25-2018
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