| Device Type ID | 47 |
| Device Name | Attachment, Breathing, Positive End Expiratory Pressure |
| Regulation Description | Positive End Expiratory Pressure Breathing Attachment. |
| 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 | 868.5965 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 47 |
| Device | Attachment, Breathing, Positive End Expiratory Pressure |
| Product Code | BYE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Positive End Expiratory Pressure Breathing Attachment. |
| CFR Regulation Number | 868.5965 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BESMED HEALTH BUSINESS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALEMED CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALEMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
S & T MEDICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Breathing Circuit | 3 |
Misassembled | 3 |
Component Missing | 2 |
Valve | 2 |
Material Discolored | 2 |
Fracture | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Blocked Connection | 2 |
Disconnection | 1 |
Pressure Problem | 1 |
Tube | 1 |
Device Packaging Compromised | 1 |
Gas Leak | 1 |
Activation, Positioning Or Separation Problem | 1 |
Gradient Increase | 1 |
Connection Problem | 1 |
| Total Device Problems | 26 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Airways Development LLC | II | Dec-24-2015 |