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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description Carbon dioxide gas analyzer.
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K192446  CO2 Mainstream Module
  2.  K192488  CO2 Sidestream Module
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
INVENTEUR, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 1216 1216
2025 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3416 3416
Communication or Transmission Problem 2791 2791
Crack 2432 2432
Corroded 1022 1022
Failure to Calibrate 949 949
Appropriate Term/Code Not Available 945 945
Incorrect, Inadequate or Imprecise Result or Readings 734 734
Device Alarm System 662 662
Computer Software Problem 564 564
Contamination 530 530
Failure of Device to Self-Test 486 486
No Device Output 482 482
Loose or Intermittent Connection 430 430
No Apparent Adverse Event 416 416
Calibration Problem 406 406
Circuit Failure 302 302
Insufficient Information 295 295
Output Problem 223 223
Device Sensing Problem 181 181
Physical Resistance/Sticking 126 126
Failure to Read Input Signal 110 110
Display or Visual Feedback Problem 83 83
Display Difficult to Read 77 77
Missing Information 68 68
Incorrect Measurement 63 63
Application Program Freezes, Becomes Nonfunctional 62 62
Unable to Obtain Readings 58 58
Low Readings 50 50
Misassembled 49 49
High Readings 41 41
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Application Program Problem 29 29
Naturally Worn 28 28
Degraded 28 28
Failure to Cycle 25 25
Electrical /Electronic Property Problem 25 25
Power Problem 22 22
Gas Output Problem 21 21
Temperature Problem 21 21
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 14 14
Unexpected Shutdown 13 13
False Alarm 12 12
Use of Device Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7131 7131
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
Insufficient Information 129 129
No Known Impact Or Consequence To Patient 114 114
No Information 81 81
Unintended Extubation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Cardiac Arrest 5 5
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
Respiratory Failure 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 Mar-17-2025
6 Oridion Medical 1987 Ltd. II Oct-03-2018
7 Smiths Medical ASD Inc. II Jul-06-2018
8 Smiths Medical ASD, Inc. II Mar-20-2025
9 Southmedic, Inc. II Jul-24-2021
10 Southmedic, Inc. II Jan-25-2018
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