| Device Type ID | 1946 |
| Device Name | Set, Administration, For Peritoneal Dialysis, Disposable |
| 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 | KDJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1946 |
| Device | Set, Administration, For Peritoneal Dialysis, Disposable |
| Product Code | KDJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Peritoneal Dialysis System And Accessories. |
| CFR Regulation Number | 876.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAXTER HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAXTER HEALTHCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAXTER HEALTHCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS MEDICAL CARE NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PURACATH MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11618 |
Improper Or Incorrect Procedure Or Method | 2581 |
Absorber | 1232 |
Fluid Leak | 1048 |
Cap | 954 |
Crack | 757 |
Detachment Of Device Or Device Component | 731 |
Disconnection | 540 |
Connector | 497 |
Product Quality Problem | 425 |
Loose Or Intermittent Connection | 267 |
Tube | 267 |
Clamp | 266 |
Break | 248 |
Housing | 213 |
Unsealed Device Packaging | 160 |
Device Contamination With Chemical Or Other Material | 142 |
Connection Problem | 123 |
Packaging Problem | 91 |
Misassembled | 83 |
Component Missing | 82 |
Foil | 73 |
Leak / Splash | 71 |
Hole In Material | 69 |
Locking Sleeve | 61 |
Fitting Problem | 60 |
Detachment Of Device Component | 55 |
Device Displays Incorrect Message | 44 |
Device Operates Differently Than Expected | 42 |
Tear, Rip Or Hole In Device Packaging | 35 |
Seal | 35 |
Adapter (Adaptor) | 32 |
Use Of Device Problem | 22 |
Failure To Disconnect | 18 |
Device Packaging Compromised | 18 |
Cut In Material | 16 |
Mechanical Problem | 15 |
Improper Flow Or Infusion | 14 |
Bags | 14 |
Insufficient Information | 13 |
Misconnection | 12 |
Material Split, Cut Or Torn | 11 |
Material Separation | 11 |
No Flow | 10 |
Material Integrity Problem | 10 |
Y-Piece Connector | 9 |
Material Puncture / Hole | 9 |
Material Deformation | 9 |
Shield | 7 |
Delivered As Unsterile Product | 6 |
Cassette | 6 |
Spacer | 5 |
Radiation Underexposure | 5 |
Device Handling Problem | 4 |
Separation Failure | 3 |
Material Rupture | 3 |
Kinked | 3 |
Material Perforation | 3 |
Label | 3 |
Degraded | 3 |
Catheter | 3 |
Contamination During Use | 3 |
Port | 3 |
Valve | 3 |
Defective Component | 2 |
Expiration Date Error | 2 |
Fracture | 2 |
Labelling, Instructions For Use Or Training Problem | 2 |
Device Markings / Labelling Problem | 2 |
Incomplete Or Inadequate Connection | 2 |
Partial Blockage | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Ring | 1 |
Overlay | 1 |
Free Or Unrestricted Flow | 1 |
Scratched Material | 1 |
Component Falling | 1 |
Valve, Flow | 1 |
Microbial Contamination Of Device | 1 |
Noise, Audible | 1 |
Failure To Prime | 1 |
Device Reprocessing Problem | 1 |
Infusion Or Flow Problem | 1 |
Luer Valve | 1 |
Suction Problem | 1 |
Overfill | 1 |
Obstruction Of Flow | 1 |
| Total Device Problems | 23205 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp | II | Oct-17-2014 |
| 2 | Baxter Healthcare Corp. | II | Oct-30-2015 |
| 3 | Baxter Healthcare Corp. | II | Aug-27-2015 |
| 4 | Baxter Healthcare Corporation | II | Jun-02-2017 |