| Device Type ID | 85 |
| Device Name | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Regulation Description | Anesthesia Breathing Circuit. |
| 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 | 868.5240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CAI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 85 |
| Device | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Product Code | CAI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Anesthesia Breathing Circuit. |
| CFR Regulation Number | 868.5240 [🔎] |
| Device Problems | |
|---|---|
Disconnection | 138 |
Breathing Circuit | 131 |
Product Quality Problem | 100 |
Leak / Splash | 86 |
Filter | 54 |
Crack | 48 |
Humidifier | 46 |
Gas Leak | 34 |
Loose Or Intermittent Connection | 25 |
Y-Piece Connector | 22 |
System | 17 |
Tube | 16 |
Air Leak | 16 |
Device Alarm System | 10 |
Connection Problem | 8 |
Degraded | 8 |
Detachment Of Device Component | 7 |
Occlusion Within Device | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Break | 5 |
Melted | 4 |
Device Operates Differently Than Expected | 4 |
Fracture | 3 |
Use Of Device Problem | 3 |
No Flow | 3 |
Cut In Material | 3 |
Hole In Material | 3 |
Material Separation | 2 |
Insufficient Information | 2 |
Material Rupture | 2 |
Loss Of Or Failure To Bond | 2 |
Device Displays Incorrect Message | 2 |
Misassembled | 2 |
Tears, Rips, Holes In Device, Device Material | 2 |
Communication Or Transmission Problem | 1 |
Infusion Or Flow Problem | 1 |
Port | 1 |
Ventilation Problem In Device Environment | 1 |
Component Missing | 1 |
Failure To Deliver | 1 |
Obstruction Of Flow | 1 |
Tidal Volume Fluctuations | 1 |
Gas Output Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Premature Separation | 1 |
Connector | 1 |
Detachment Of Device Or Device Component | 1 |
Material Perforation | 1 |
Protective Measures Problem | 1 |
Misassembly By Users | 1 |
Partial Blockage | 1 |
Device Subassembly | 1 |
| Total Device Problems | 837 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Intersurgical Inc | II | Jun-27-2018 |
| 2 | Teleflex Medical | I | Sep-30-2014 |
| 3 | Teleflex Medical | II | Jul-23-2014 |