| Device Type ID | 82 |
| Device Name | Airway, Oropharyngeal, Anesthesiology |
| Regulation Description | Oropharyngeal Airway. |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5110 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 82 |
| Device | Airway, Oropharyngeal, Anesthesiology |
| Product Code | CAE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Oropharyngeal Airway. |
| CFR Regulation Number | 868.5110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LARYNGEAL MASK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Deflation Problem | 42 |
Device Operates Differently Than Expected | 40 |
Inflation Problem | 21 |
Leak / Splash | 20 |
Break | 14 |
Crack | 10 |
Material Separation | 9 |
Shelf Life Exceeded | 7 |
Hole In Material | 6 |
Sticking | 4 |
Detachment Of Device Component | 4 |
Material Deformation | 4 |
Material Rupture | 4 |
Device Damaged Prior To Use | 4 |
Misassembled | 4 |
Occlusion Within Device | 3 |
Difficult To Insert | 3 |
Detachment Of Device Or Device Component | 3 |
Torn Material | 3 |
Air Leak | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Mechanical Problem | 2 |
Disconnection | 2 |
Device Markings / Labelling Problem | 2 |
Connection Problem | 2 |
Obstruction Of Flow | 2 |
Gas Leak | 2 |
Human-Device Interface Problem | 1 |
Difficult To Remove | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Integrity Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Loss Of Or Failure To Bond | 1 |
Cuff | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Difficult To Position | 1 |
Material Perforation | 1 |
Split | 1 |
Defective Device | 1 |
Physical Resistance / Sticking | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Material Fragmentation | 1 |
Material Too Rigid Or Stiff | 1 |
| Total Device Problems | 242 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Besmed Health Business Corporation | II | Oct-15-2018 |
| 2 | Carefusion 2200 Inc | II | Sep-20-2016 |
| 3 | King Systems Corp. | II | Jan-10-2014 |
| 4 | Microtek Medical Inc | II | Jun-26-2015 |
| 5 | Teleflex Medical | II | Feb-10-2015 |