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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, airway pressure (includes gauge and/or alarm)
Product CodeCAP
Regulation Number 868.2600
Device Class 2


Premarket Reviews
ManufacturerDecision
A PLUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BESMED HEALTH BUSINESS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRW MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOFORCE GROUP INC
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB CORP.
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 3
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 5 5
2022 6 6
2023 11 11
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 5 5
Output Problem 5 5
Device Emits Odor 3 3
Decrease in Pressure 3 3
Unintended Deflation 3 3
Failure to Zero 2 2
Defective Device 2 2
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Pressure 1 1
Premature Indicator Activation 1 1
Pressure Problem 1 1
Inaccurate Information 1 1
No Device Output 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Inflation Problem 1 1
Incorrect Measurement 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 6 6
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
No Information 1 1

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