Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
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
1. K171828
ETCO2 Sensor
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
1
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
948
948
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3329
3329
Communication or Transmission Problem
2518
2518
Crack
2316
2316
Corroded
951
951
Appropriate Term/Code Not Available
944
944
Failure to Calibrate
879
879
Incorrect, Inadequate or Imprecise Result or Readings
733
733
Device Alarm System
618
618
Computer Software Problem
564
564
Contamination
522
522
Failure of Device to Self-Test
475
475
No Device Output
466
466
No Apparent Adverse Event
412
412
Loose or Intermittent Connection
408
408
Calibration Problem
371
371
Circuit Failure
300
300
Insufficient Information
295
295
Output Problem
218
218
Device Sensing Problem
180
180
Physical Resistance/Sticking
118
118
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
56
56
Incorrect Measurement
49
49
Misassembled
48
48
Failure to Power Up
39
39
Peeled/Delaminated
38
38
Pumping Stopped
37
37
High Readings
35
35
Low Readings
34
34
Missing Information
31
31
Degraded
28
28
Naturally Worn
28
28
Application Program Problem
26
26
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
Unexpected Shutdown
13
13
Noise, Audible
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
6611
6611
No Patient Involvement
2990
2990
No Consequences Or Impact To Patient
132
132
Insufficient Information
121
121
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
7
7
Unspecified Tissue Injury
4
4
Foreign Body In Patient
3
3
Cardiac Arrest
3
3
Hypoxia
2
2
Death
2
2
Low Oxygen Saturation
2
2
Respiratory Distress
2
2
Patient Problem/Medical Problem
1
1
Superficial (First Degree) Burn
1
1
Cough
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Lethargy
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoventilation
1
1
Pressure Sores
1
1
Anxiety
1
1
Discomfort
1
1
Injury
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Laceration(s)
1
1
Pain
1
1
Perforation
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Cyanosis
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
-
-