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
nebulizer (direct patient interface)
Product Code
CAF
Regulation Number
868.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADHERIUM (NZ) LTD
SUBSTANTIALLY EQUIVALENT
6
AEROGEN LTD.
SUBSTANTIALLY EQUIVALENT
1
AIREHEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHESUITE INC
SUBSTANTIALLY EQUIVALENT
1
COGNITA LABS, LLC
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
SUBSTANTIALLY EQUIVALENT
1
EXCELLENTCARE MEDICAL (HUIZHOU) LTD.
SUBSTANTIALLY EQUIVALENT
1
FEELLIFE HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K192633
GUS831 Compressor Nebulizer
HCMED INNOVATIONS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MANKIND PHARMA LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTIRES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES LP
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
MONAGHAN MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OCHSNER CLINIC FOUNDATION
SUBSTANTIALLY EQUIVALENT
1
PARI RESPIRATORY EQUIPMENT, INC.
SUBSTANTIALLY EQUIVALENT
2
RECIPROCAL LABS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
THE RITEDOSE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
2
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
185
185
2020
117
117
2021
161
161
2022
55
55
2023
104
104
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver
155
155
Connection Problem
55
55
Leak/Splash
44
44
Break
35
35
Disconnection
23
23
Fluid/Blood Leak
18
18
Defective Device
18
18
Use of Device Problem
17
17
Mechanical Problem
16
16
Improper Flow or Infusion
15
15
Output Problem
13
13
Therapeutic or Diagnostic Output Failure
13
13
Fire
12
12
Insufficient Information
11
11
Infusion or Flow Problem
10
10
Patient Device Interaction Problem
10
10
Material Rupture
10
10
Defective Component
10
10
Gas/Air Leak
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Fitting Problem
8
8
Smoking
7
7
Detachment of Device or Device Component
7
7
Electrical /Electronic Property Problem
7
7
Appropriate Term/Code Not Available
7
7
No Flow
7
7
Unexpected Shutdown
6
6
Degraded
5
5
Contamination
5
5
Loose or Intermittent Connection
5
5
Melted
5
5
Overheating of Device
5
5
Failure to Power Up
5
5
Sparking
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Component Missing
5
5
Inaccurate Delivery
4
4
Improper or Incorrect Procedure or Method
4
4
Product Quality Problem
4
4
Material Integrity Problem
4
4
Off-Label Use
3
3
Device Emits Odor
3
3
Corroded
3
3
Thermal Decomposition of Device
3
3
Insufficient Flow or Under Infusion
3
3
Obstruction of Flow
3
3
Device Displays Incorrect Message
3
3
Malposition of Device
2
2
Charging Problem
2
2
Electrical Shorting
2
2
Decrease in Pressure
2
2
Device Contamination with Chemical or Other Material
2
2
Incomplete or Missing Packaging
2
2
Burst Container or Vessel
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Packaging Problem
2
2
Material Split, Cut or Torn
2
2
Pressure Problem
2
2
Protective Measures Problem
2
2
Temperature Problem
2
2
Complete Loss of Power
2
2
Separation Problem
2
2
Explosion
1
1
Failure to Eject
1
1
Physical Resistance/Sticking
1
1
Excessive Heating
1
1
Incomplete or Inadequate Connection
1
1
Power Problem
1
1
No Pressure
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Noise, Audible
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Failure to Charge
1
1
Component Incompatible
1
1
No Audible Alarm
1
1
Loss of or Failure to Bond
1
1
Material Disintegration
1
1
Display or Visual Feedback Problem
1
1
Fracture
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Labelling, Instructions for Use or Training Problem
1
1
No Device Output
1
1
Nonstandard Device
1
1
Incorrect Measurement
1
1
Restricted Flow rate
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Run on Battery
1
1
Inappropriate Audible Prompt/Feedback
1
1
Difficult or Delayed Activation
1
1
Unexpected Therapeutic Results
1
1
Material Too Rigid or Stiff
1
1
Material Separation
1
1
Failure to Shut Off
1
1
Device Ingredient or Reagent Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
239
239
No Consequences Or Impact To Patient
149
149
Insufficient Information
60
60
No Known Impact Or Consequence To Patient
59
59
No Patient Involvement
52
52
Low Oxygen Saturation
11
11
Dyspnea
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Respiratory Problem
7
7
Unintended Extubation
5
5
Aspiration/Inhalation
5
5
No Information
4
4
Swelling/ Edema
3
3
Asthma
3
3
Dizziness
3
3
Pneumothorax
2
2
Urinary Frequency
2
2
Sore Throat
2
2
Unspecified Infection
2
2
Itching Sensation
2
2
Respiratory Distress
2
2
Bacterial Infection
2
2
Bradycardia
2
2
Burn(s)
2
2
Airway Obstruction
2
2
Apnea
2
2
Arrhythmia
2
2
Headache
2
2
Hypersensitivity/Allergic reaction
2
2
Cough
2
2
Pulmonary Hypertension
2
2
Respiratory Insufficiency
2
2
Fibrosis
2
2
High Pulmonary Arterial Wedge Pressure
2
2
Bronchospasm
2
2
Increased Respiratory Rate
2
2
Sleep Dysfunction
1
1
Eye Burn
1
1
Burn, Thermal
1
1
Underdose
1
1
Electric Shock
1
1
Missed Dose
1
1
Chemical Exposure
1
1
Decreased Respiratory Rate
1
1
No Code Available
1
1
Heart Failure/Congestive Heart Failure
1
1
Wheezing
1
1
Respiratory Arrest
1
1
Skin Inflammation/ Irritation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Hemorrhage/Bleeding
1
1
Fatigue
1
1
Chest Pain
1
1
Cyanosis
1
1
Death
1
1
Right Ventricular Dysfunction
1
1
Tachycardia
1
1
Burning Sensation
1
1
Hot Flashes/Flushes
1
1
Occlusion
1
1
Peeling
1
1
Pneumonia
1
1
Ulcer
1
1
Pulmonary Edema
1
1
Rash
1
1
Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
I
Sep-14-2023
2
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
I
Feb-04-2019
3
SANRAI INTERNATIONAL LLC
II
Mar-26-2019
4
Smiths Medical ASD Inc.
II
Apr-29-2021
-
-