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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
BARBARAS DEVELOPMENT INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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
NIHON KOHDEN CORPORATION
  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
  1.  K172365  Panoramic Oxygen Mask (POM)
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 1217 1217
2025 568 568

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3444 3444
Communication or Transmission Problem 2951 2951
Crack 2496 2496
Corroded 1049 1049
Failure to Calibrate 963 963
Appropriate Term/Code Not Available 945 945
Incorrect, Inadequate or Imprecise Result or Readings 738 738
Device Alarm System 691 691
Computer Software Problem 564 564
Contamination 530 530
Failure of Device to Self-Test 490 490
No Device Output 486 486
Loose or Intermittent Connection 441 441
Calibration Problem 419 419
No Apparent Adverse Event 417 417
Circuit Failure 304 304
Insufficient Information 295 295
Output Problem 230 230
Device Sensing Problem 181 181
Physical Resistance/Sticking 126 126
Missing Information 117 117
Failure to Read Input Signal 110 110
Display or Visual Feedback Problem 85 85
Display Difficult to Read 78 78
Unable to Obtain Readings 69 69
Incorrect Measurement 67 67
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 52 52
Misassembled 49 49
High Readings 42 42
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 38 38
Application Program Problem 30 30
Naturally Worn 28 28
Degraded 28 28
Gas Output Problem 27 27
Failure to Cycle 25 25
Electrical /Electronic Property Problem 25 25
Power Problem 23 23
Image Display Error/Artifact 22 22
Temperature Problem 21 21
No Display/Image 18 18
Mechanical Problem 18 18
Device Markings/Labelling Problem 15 15
Noise, Audible 14 14
Unexpected Shutdown 14 14
Erratic or Intermittent Display 14 14
Defective Component 13 13
False Alarm 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7433 7433
No Patient Involvement 2990 2990
Insufficient Information 134 134
No Consequences Or Impact To Patient 132 132
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 9 9
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
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 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
Lethargy 1 1
Bruise/Contusion 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 Philips North America Llc II May-05-2025
8 Smiths Medical ASD Inc. II Jul-06-2018
9 Smiths Medical ASD, Inc. II Mar-20-2025
10 Southmedic, Inc. II Jul-24-2021
11 Southmedic, Inc. II Jan-25-2018
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