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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
  1.  K203762  Nellcor EASYCAP II Adult Colorimetric CO2 Detector ...
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 1217 1217
2025 502 502

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3434 3434
Communication or Transmission Problem 2909 2909
Crack 2472 2472
Corroded 1027 1027
Failure to Calibrate 962 962
Appropriate Term/Code Not Available 945 945
Incorrect, Inadequate or Imprecise Result or Readings 737 737
Device Alarm System 684 684
Computer Software Problem 564 564
Contamination 530 530
Failure of Device to Self-Test 490 490
No Device Output 483 483
Loose or Intermittent Connection 439 439
Calibration Problem 419 419
No Apparent Adverse Event 416 416
Circuit Failure 304 304
Insufficient Information 295 295
Output Problem 225 225
Device Sensing Problem 181 181
Physical Resistance/Sticking 126 126
Missing Information 115 115
Failure to Read Input Signal 110 110
Display or Visual Feedback Problem 83 83
Display Difficult to Read 77 77
Incorrect Measurement 66 66
Unable to Obtain Readings 64 64
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 52 52
Misassembled 49 49
High Readings 41 41
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Application Program Problem 30 30
Degraded 28 28
Naturally Worn 28 28
Electrical /Electronic Property Problem 25 25
Failure to Cycle 25 25
Power Problem 23 23
Gas Output Problem 22 22
Temperature Problem 21 21
Image Display Error/Artifact 20 20
Mechanical Problem 18 18
No Display/Image 17 17
Device Markings/Labelling Problem 15 15
Noise, Audible 14 14
Unexpected Shutdown 14 14
Erratic or Intermittent Display 14 14
Defective Component 13 13
Obstruction of Flow 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7369 7369
No Patient Involvement 2990 2990
Insufficient Information 132 132
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
Respiratory Failure 2 2
Death 2 2
Hypoxia 2 2
Pain 2 2
Respiratory Distress 2 2
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Bruise/Contusion 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Laceration(s) 1 1
Perforation 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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