| Device Type ID | 1878 |
| Device Name | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Regulation Description | Hemodialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FJK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1878 |
| Device | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Product Code | FJK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIMESOL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOME DIALYSIS PLUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 220 |
Adverse Event Without Identified Device Or Use Problem | 120 |
Leak / Splash | 51 |
Insufficient Information | 42 |
Disconnection | 40 |
Air Leak | 22 |
Connection Problem | 18 |
Loose Or Intermittent Connection | 15 |
Crack | 13 |
Detachment Of Device Component | 12 |
Device Dislodged Or Dislocated | 11 |
Occlusion Within Device | 10 |
Device Operates Differently Than Expected | 10 |
Material Separation | 10 |
Misconnection | 8 |
Hole In Material | 7 |
Tube | 6 |
Failure To Adhere Or Bond | 6 |
Migration Or Expulsion Of Device | 5 |
Device Operational Issue | 4 |
Device Displays Incorrect Message | 4 |
No Fail-Safe Mechanism | 4 |
Kinked | 4 |
Material Rupture | 3 |
Material Perforation | 3 |
Break | 3 |
Split | 3 |
Detachment Of Device Or Device Component | 3 |
Coagulation In Device Or Device Ingredient | 3 |
Increase In Pressure | 3 |
Material Puncture / Hole | 3 |
No Apparent Adverse Event | 2 |
Use Of Device Problem | 2 |
Burst Container Or Vessel | 2 |
Defective Component | 2 |
Filtration Problem | 2 |
Device Slipped | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Device Maintenance Issue | 2 |
Decrease In Pressure | 2 |
Inadequate Filtration Process | 1 |
Unintended Movement | 1 |
Partial Blockage | 1 |
Device Damaged By Another Device | 1 |
Alarm System, Failure Of Check-catheter | 1 |
Filling Problem | 1 |
Improper Flow Or Infusion | 1 |
Cut In Material | 1 |
Torn Material | 1 |
Connector | 1 |
Device Alarm System | 1 |
Emergency Stop Button Or Switch Failure | 1 |
Patient-Device Incompatibility | 1 |
Suction Problem | 1 |
Obstruction Of Flow | 1 |
Difficult To Open Or Close | 1 |
Appropriate Term/Code Not Available | 1 |
Smoking | 1 |
Couple, Failure To | 1 |
| Total Device Problems | 703 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Gambro Renal Products, Incorporated | II | Apr-11-2014 |
| 2 | Nipro Medical Corporation | II | May-15-2018 |
| 3 | Nipro Medical Corporation | II | Jan-08-2016 |