• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 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
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
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 1216 1216
2025 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3411 3411
Communication or Transmission Problem 2790 2790
Crack 2430 2430
Corroded 1022 1022
Failure to Calibrate 948 948
Appropriate Term/Code Not Available 942 942
Incorrect, Inadequate or Imprecise Result or Readings 710 710
Device Alarm System 659 659
Computer Software Problem 562 562
Contamination 530 530
Failure of Device to Self-Test 486 486
No Device Output 470 470
Loose or Intermittent Connection 429 429
No Apparent Adverse Event 416 416
Calibration Problem 393 393
Circuit Failure 300 300
Insufficient Information 294 294
Device Sensing Problem 175 175
Output Problem 166 166
Physical Resistance/Sticking 126 126
Failure to Read Input Signal 109 109
Missing Information 68 68
Display Difficult to Read 68 68
Display or Visual Feedback Problem 67 67
Application Program Freezes, Becomes Nonfunctional 62 62
Incorrect Measurement 56 56
Misassembled 49 49
Low Readings 44 44
Unable to Obtain Readings 44 44
High Readings 39 39
Peeled/Delaminated 38 38
Pumping Stopped 36 36
Failure to Power Up 31 31
Degraded 28 28
Application Program Problem 28 28
Naturally Worn 26 26
Failure to Cycle 23 23
Electrical /Electronic Property Problem 23 23
Temperature Problem 21 21
Image Display Error/Artifact 18 18
Device Markings/Labelling Problem 15 15
No Display/Image 15 15
Mechanical Problem 13 13
False Alarm 12 12
Erratic or Intermittent Display 12 12
Power Problem 12 12
Noise, Audible 11 11
Device Ingredient or Reagent Problem 11 11
Unexpected Shutdown 11 11
Use of Device Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7118 7118
No Patient Involvement 2965 2965
Insufficient Information 129 129
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 8 8
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
Bruise/Contusion 1 1
Lethargy 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 Smiths Medical ASD, Inc. II Mar-20-2025
6 Southmedic, Inc. II Jul-24-2021
-
-