| Device Type ID | 1966 |
| Device Name | Accessories, Blood Circuit, Hemodialysis |
| 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 | KOC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1966 |
| Device | Accessories, Blood Circuit, Hemodialysis |
| Product Code | KOC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRESENIUS MEDICAL CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS MEDICAL CARE NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 671 |
Disconnection | 46 |
Adverse Event Without Identified Device Or Use Problem | 19 |
Crack | 10 |
Thermal Decomposition Of Device | 7 |
Leak / Splash | 7 |
Loose Or Intermittent Connection | 3 |
Connection Problem | 3 |
Inadequate Ultra Filtration | 2 |
Failure To Adhere Or Bond | 1 |
Misconnection | 1 |
Fire | 1 |
Sparking | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Insufficient Heating | 1 |
Misassembled | 1 |
Occlusion Within Device | 1 |
Smoking | 1 |
Overheating Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Insufficient Information | 1 |
Device-Device Incompatibility | 1 |
Detachment Of Device Component | 1 |
Air Leak | 1 |
| Total Device Problems | 784 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fresenius Medical Care Holdings, Inc. | II | Jun-05-2015 |
| 2 | Fresenius Medical Care Holdings, Inc. | II | Feb-03-2015 |
| 3 | Fresenius Medical Care Renal Therapies Group, LLC | II | Jun-21-2016 |
| 4 | Molded Products Inc | II | Mar-24-2017 |
| 5 | Stihler Electronic Gmbh | II | Jan-23-2019 |