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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
BARBARAS DEVELOPMENT INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 1
INVENTEUR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 1
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 3439 3439
Communication or Transmission Problem 2950 2950
Crack 2494 2494
Corroded 1049 1049
Failure to Calibrate 962 962
Appropriate Term/Code Not Available 942 942
Incorrect, Inadequate or Imprecise Result or Readings 714 714
Device Alarm System 688 688
Computer Software Problem 562 562
Contamination 530 530
Failure of Device to Self-Test 490 490
No Device Output 474 474
Loose or Intermittent Connection 440 440
No Apparent Adverse Event 417 417
Calibration Problem 406 406
Circuit Failure 302 302
Insufficient Information 294 294
Device Sensing Problem 175 175
Output Problem 173 173
Physical Resistance/Sticking 126 126
Missing Information 117 117
Failure to Read Input Signal 109 109
Display or Visual Feedback Problem 69 69
Display Difficult to Read 69 69
Application Program Freezes, Becomes Nonfunctional 62 62
Incorrect Measurement 60 60
Unable to Obtain Readings 55 55
Misassembled 49 49
Low Readings 46 46
High Readings 40 40
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Failure to Power Up 31 31
Application Program Problem 29 29
Degraded 28 28
Naturally Worn 26 26
Failure to Cycle 23 23
Electrical /Electronic Property Problem 23 23
Image Display Error/Artifact 21 21
Temperature Problem 21 21
No Display/Image 16 16
Device Markings/Labelling Problem 15 15
Gas Output Problem 15 15
Power Problem 13 13
Mechanical Problem 13 13
Erratic or Intermittent Display 12 12
Unexpected Shutdown 12 12
False Alarm 12 12
Defective Component 12 12
Obstruction of Flow 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7420 7420
No Patient Involvement 2965 2965
Insufficient Information 134 134
No Consequences Or Impact To Patient 78 78
No Information 55 55
No Known Impact Or Consequence To Patient 25 25
Unintended Extubation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Cardiac Arrest 5 5
Unspecified Tissue Injury 4 4
Low Oxygen Saturation 2 2
Respiratory Failure 2 2
Superficial (First Degree) Burn 1 1
Death 1 1
Hypoventilation 1 1
Respiratory Arrest 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Discomfort 1 1
Laceration(s) 1 1
Pain 1 1
Anxiety 1 1
Cough 1 1
Hypoxia 1 1
Extubate 1 1
Respiratory Insufficiency 1 1
Lethargy 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Dec-01-2020
2 GE Healthcare, LLC I Jan-10-2020
3 Nihon Kohden America Inc II Nov-06-2024
4 Oridion Medical 1987 Ltd. II Mar-17-2025
5 Philips North America Llc II May-05-2025
6 Smiths Medical ASD, Inc. II Mar-20-2025
7 Southmedic, Inc. II Jul-24-2021
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