| Device Type ID | 1912 |
| Device Name | System, Peritoneal, Automatic Delivery |
| Regulation Description | Peritoneal Dialysis 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 | 876.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FKX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1912 |
| Device | System, Peritoneal, Automatic Delivery |
| Product Code | FKX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Peritoneal Dialysis System And Accessories. |
| CFR Regulation Number | 876.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS MEDICAL CARE NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 6659 |
Fluid Leak | 6521 |
Adverse Event Without Identified Device Or Use Problem | 4404 |
Device Operates Differently Than Expected | 3837 |
Improper Or Incorrect Procedure Or Method | 3221 |
Overfill | 924 |
Connector | 742 |
Disconnection | 653 |
Thermal Decomposition Of Device | 622 |
Tube | 610 |
Loose Or Intermittent Connection | 423 |
Cassette | 395 |
Device Handling Problem | 356 |
Volume Accuracy Problem | 219 |
Device Contamination With Chemical Or Other Material | 204 |
Hole In Material | 200 |
Overheating Of Device | 105 |
Cut In Material | 101 |
Cap | 100 |
Break | 88 |
Insufficient Information | 85 |
Improper Flow Or Infusion | 83 |
Component Missing | 82 |
Leak / Splash | 76 |
Crack | 75 |
Connection Problem | 69 |
Device Emits Odor | 49 |
Bags | 43 |
Use Of Device Problem | 40 |
Grounding Malfunction | 39 |
Smoking | 34 |
Device Alarm System | 32 |
Material Puncture / Hole | 28 |
Fitting Problem | 27 |
Device Issue | 24 |
Degraded | 23 |
Material Split, Cut Or Torn | 23 |
Sparking | 23 |
Barrier | 22 |
Electrical /Electronic Property Problem | 21 |
Air Leak | 20 |
Melted | 15 |
Material Integrity Problem | 14 |
Misassembled | 13 |
Material Perforation | 12 |
Clamp | 11 |
Material Deformation | 9 |
Filling Problem | 9 |
Kinked | 9 |
Material Rupture | 9 |
Tear, Rip Or Hole In Device Packaging | 9 |
Bent | 8 |
Occlusion Within Device | 8 |
Invalid Sensing | 8 |
Noise, Audible | 8 |
Detachment Of Device Or Device Component | 8 |
Mechanical Problem | 7 |
Detachment Of Device Component | 7 |
Inappropriate Shock | 7 |
Temperature Problem | 6 |
Membrane | 5 |
Failure To Disconnect | 5 |
Housing | 5 |
Scratched Material | 5 |
Image Display Error / Artifact | 5 |
Reflux Within Device | 5 |
Absorber | 5 |
Insufficient Heating | 5 |
Appropriate Term/Code Not Available | 5 |
Port | 4 |
Device Inoperable | 4 |
Fire | 4 |
Plug | 4 |
Partial Blockage | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Torn Material | 3 |
Electrical Shorting | 3 |
Delivery System Issue, No Description | 3 |
Device Operational Issue | 3 |
Misconnection | 3 |
Contamination During Use | 2 |
Inadequate Ultra Filtration | 2 |
Power Problem | 2 |
Device Contamination With Body Fluid | 2 |
Failure To Cycle | 2 |
No Display / Image | 2 |
Incorrect Measurement | 2 |
No Audible Alarm | 2 |
Device Dislodged Or Dislocated | 2 |
Power Cord | 2 |
Material Separation | 2 |
Foil | 2 |
Locking Sleeve | 2 |
Automatic Injection System Overinfusion | 1 |
Restricted Flow Rate | 1 |
Ambient Noise Problem | 1 |
Difficult To Insert | 1 |
Moisture Damage | 1 |
Spring Loading Mechanism | 1 |
Heat Exchanger | 1 |
| Total Device Problems | 31596 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp | II | Sep-14-2017 |
| 2 | Baxter Healthcare Corp. | II | Aug-22-2016 |
| 3 | Baxter Healthcare Corp. | II | Apr-25-2016 |
| 4 | Baxter Healthcare Corp. | III | Nov-17-2015 |
| 5 | Baxter Healthcare Corp. | II | Mar-18-2015 |
| 6 | Baxter Healthcare Corp. | II | Feb-02-2015 |
| 7 | Baxter Healthcare Corp. | II | Jan-29-2015 |
| 8 | Baxter Healthcare Corp. | II | Jan-07-2015 |
| 9 | Baxter Healthcare Corp. | II | Jan-07-2015 |
| 10 | Baxter Healthcare Corporation | II | Feb-20-2019 |
| 11 | Baxter Healthcare Corporation | II | Aug-02-2018 |
| 12 | Baxter Healthcare Corporation | II | Aug-16-2017 |
| 13 | Baxter Healthcare Corporation | II | Jan-19-2017 |
| 14 | Fresenius Medical Care Renal Therapies Group, LLC | II | Apr-12-2018 |
| 15 | Fresenius Medical Care Renal Therapies Group, LLC | II | Jan-27-2016 |