Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 monitor, airway pressure (includes gauge and/or alarm)
Regulation Description Airway pressure monitor.
Product CodeCAP
Regulation Number 868.2600
Device Class 2


Premarket Reviews
ManufacturerDecision
FLEXICARE MEDICAL LIMITED.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 2
2021 5 5
2022 6 6
2023 11 11
2024 11 11
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 5 5
Decrease in Pressure 4 4
Unintended Deflation 3 3
Device Emits Odor 3 3
Gas/Air Leak 2 2
Defective Device 2 2
Incorrect Measurement 2 3
Failure to Zero 2 2
Pressure Problem 2 2
Contamination 1 1
Unable to Obtain Readings 1 1
Key or Button Unresponsive/not Working 1 1
Inaccurate Information 1 1
Inflation Problem 1 1
Break 1 1
Defective Component 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1
Premature Indicator Activation 1 1
No Pressure 1 1
No Device Output 1 1
Device Markings/Labelling Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Microbial Contamination of Device 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 30
Insufficient Information 6 6
No Consequences Or Impact To Patient 3 4
No Information 1 1

-
-