| Device Type ID | 83 |
| Device Name | Nebulizer (direct Patient Interface) |
| Regulation Description | Nebulizer. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 83 |
| Device | Nebulizer (direct Patient Interface) |
| Product Code | CAF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nebulizer. |
| CFR Regulation Number | 868.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADHERIUM (NZ) LTD | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
AEROGEN LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BESMED HEALTH BUSINESS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIGIO2 INTERNATIONAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION INDU | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIANATECHNOLOGIES CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEXUS6, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OMRON HEALTHCARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRE HOLDING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RECIPROCAL LABS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SUZHOU WEIKANG MEDICAL APPARATUS CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TRUDELL MEDICAL INT'L | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VECTURA GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Deliver | 205 |
Connection Problem | 106 |
Leak / Splash | 100 |
Infusion Or Flow Problem | 83 |
No Flow | 55 |
Disconnection | 44 |
Inaccurate Delivery | 37 |
Fitting Problem | 37 |
Electrical /Electronic Property Problem | 25 |
Device Operates Differently Than Expected | 18 |
Decrease In Pressure | 14 |
Peeled / Delaminated | 13 |
Degraded | 13 |
Improper Flow Or Infusion | 10 |
Detachment Of Device Or Device Component | 9 |
Break | 7 |
Fluid Leak | 7 |
Gas Leak | 7 |
Therapeutic Or Diagnostic Output Failure | 6 |
Restricted Flow Rate | 6 |
Cut In Material | 5 |
Defective Device | 5 |
Detachment Of Device Component | 5 |
Overheating Of Device | 4 |
Noise, Audible | 4 |
Material Rupture | 4 |
Component Missing | 4 |
Fire | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Inoperable | 3 |
Device Operational Issue | 3 |
Use Of Device Problem | 3 |
Loose Or Intermittent Connection | 3 |
Air Leak | 3 |
Failure To Power Up | 2 |
Material Separation | 2 |
Kinked | 2 |
Device Damaged Prior To Use | 2 |
Device Rinsing Issue | 2 |
Temperature Problem | 2 |
Insufficient Information | 2 |
Mechanical Problem | 2 |
Obstruction Of Flow | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Insufficient Heating | 2 |
Defective Component | 2 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Integrity Problem | 1 |
Device Fell | 1 |
Unstable | 1 |
Human-Device Interface Problem | 1 |
Sparking | 1 |
Burst Container Or Vessel | 1 |
Device Reprocessing Problem | 1 |
Delivered As Unsterile Product | 1 |
Occlusion Within Device | 1 |
Chemical Problem | 1 |
Material Frayed | 1 |
Activation, Positioning Or Separation Problem | 1 |
Crack | 1 |
Delivery System Failure | 1 |
Power Switch | 1 |
Filtration Problem | 1 |
Device Markings / Labelling Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Moisture Or Humidity Problem | 1 |
Complete Loss Of Power | 1 |
Thermal Decomposition Of Device | 1 |
Installation-Related Problem | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Patient Device Interaction Problem | 1 |
Hole In Material | 1 |
Incorrect Device Or Component Shipped | 1 |
No Pressure | 1 |
Pressure Problem | 1 |
| Total Device Problems | 912 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aerogen Ltd. | II | Oct-23-2014 |
| 2 | Compass Health Brands | II | Jun-06-2015 |
| 3 | Medex Cardio-Pulmonary Inc., D.b.a. Smiths Medical Company | I | Feb-04-2019 |
| 4 | Nephron Pharmaceuticals Corp. | II | Jun-27-2016 |
| 5 | Pharmacaribe Llc | II | Feb-10-2016 |
| 6 | SANRAI INTERNATIONAL LLC | II | Mar-26-2019 |
| 7 | Salter Labs | II | Feb-10-2016 |
| 8 | Salter Labs | II | Sep-17-2015 |
| 9 | Teleflex Medical | II | Dec-12-2014 |
| 10 | Thayer Medical Corporation | II | Feb-07-2017 |
| 11 | Valeant Pharmaceuticals North America LLC | II | Dec-04-2015 |
| 12 | Valeant Pharmacueticals International | II | Jan-17-2018 |
| 13 | Valeant Pharmacueticals International | II | Jan-21-2016 |