| Device Type ID | 1975 |
| Device Name | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| 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 | KPO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1975 |
| Device | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Product Code | KPO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAXTER HEALTHCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAXTER HEALTHCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BELLCO SRL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIALYSIS MEDICAL SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASOL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DI-CHEM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS MEDICAL CARE NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCKWELL MEDICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 23685 |
Adverse Event Without Identified Device Or Use Problem | 236 |
Thermal Decomposition Of Device | 51 |
Smoking | 26 |
Leak / Splash | 20 |
Melted | 14 |
Fire | 14 |
Manufacturing, Packaging Or Shipping Problem | 10 |
Microbial Contamination Of Device | 8 |
Appropriate Term/Code Not Available | 8 |
Device Operates Differently Than Expected | 7 |
Sparking | 6 |
Inadequate Ultra Filtration | 6 |
Improper Or Incorrect Procedure Or Method | 5 |
Contamination During Use | 5 |
Mechanical Problem | 5 |
Fluid Leak | 3 |
Off-Label Use | 3 |
Calibration Problem | 2 |
Filtration Problem | 2 |
No Fail-Safe Mechanism | 2 |
Overheating Of Device | 2 |
Spring Loading Mechanism | 2 |
Corroded | 2 |
Use Of Device Problem | 2 |
No Apparent Adverse Event | 2 |
Electrical /Electronic Property Problem | 1 |
Inappropriate Shock | 1 |
Imprecision | 1 |
Improper Chemical Reaction | 1 |
Crack | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Nonstandard Device | 1 |
Chemical Spillage | 1 |
Electrical Shorting | 1 |
| Total Device Problems | 24137 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp. | II | Jun-24-2016 |
| 2 | Fresenius Medical Care Holdings, Inc. | II | Aug-12-2015 |
| 3 | Fresenius Medical Care Holdings, Inc. | II | Jun-22-2015 |
| 4 | Fresenius Medical Care Holdings, Inc. | II | Sep-23-2014 |
| 5 | Fresenius Medical Care Holdings, Inc. | III | Jun-09-2014 |
| 6 | Fresenius Medical Care Holdings, Inc. | I | May-22-2014 |
| 7 | Fresenius Medical Care Renal Therapies Group, LLC | III | Nov-29-2018 |
| 8 | Fresenius Medical Care Renal Therapies Group, LLC | II | Jun-07-2018 |
| 9 | Fresenius Medical Care Renal Therapies Group, LLC | II | Mar-14-2018 |
| 10 | Fresenius Medical Care Renal Therapies Group, LLC | II | Feb-25-2016 |
| 11 | Fresenius Medical Care Renal Therapies Group, LLC | II | Nov-18-2015 |
| 12 | NxStage Medical, Inc. | II | Nov-27-2018 |
| 13 | NxStage Medical, Inc. | II | Mar-19-2018 |
| 14 | NxStage Medical, Inc. | II | Feb-24-2014 |
| 15 | Rockwell Medical, Inc | II | May-14-2018 |