Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
monitor, airway pressure (includes gauge and/or alarm)
Product Code
CAP
Regulation Number
868.2600
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K122077
MANOMETER
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
-
-