KDJ — Set, Administration, For Peritoneal Dialysis, Disposable Class II
FDA product code KDJ covers "Set, Administration, For Peritoneal Dialysis, Disposable", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDJ
- Device Class
- Class II
- Regulation Number
- 876.5630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250404 | fresenius medical care renal therapies group | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter | April 3, 2025 |
| K231849 | baxter healthcare | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap E | March 12, 2024 |
| K214016 | baxter healthcare corporation | 15L Cycler Drainage Bag | March 18, 2022 |
| K192705 | baxter healthcare | MiniCap Extended Life PD Transfer Sets | October 25, 2019 |
| K173593 | fresenius medical care renal therapies group | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter ext | May 21, 2018 |
| K173651 | fresenius medical care renal therapies group | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | February 14, 2018 |
| K173363 | fresenius medical care renal therapies group | Cycler Drain Bag Set | January 24, 2018 |
| K151620 | puracath medical | Firefly Peritoneal Dialysis Connector Disinfection System | January 20, 2016 |
| K152129 | baxter healthcare corporation | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod | October 29, 2015 |
| K152675 | baxter healthcare | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A | October 29, 2015 |
| K124024 | fresensius medical care north america | APD LUER-LOCK ADAPTER | September 19, 2013 |
| K083542 | fresenius medical care north america | FRESENIUS STERILE STAY SAFE CAP | December 29, 2008 |
| K042900 | k.e.p | K.E.P. CONNECTOR AND CLIP | November 5, 2004 |
| K041792 | fresenius medical care north america | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 | September 24, 2004 |
| K031676 | baxter healthcare | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C830 | November 20, 2003 |
| K022412 | fresenius medical care north america | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR | March 5, 2003 |
| K974387 | microwave medical systems | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET | September 1, 1999 |
| K972579 | baxter healthcare | HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT | October 1, 1997 |
| K972731 | klein-baker medical | NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET | September 29, 1997 |
| K963668 | medisystems | MEDISYSTEMS PERITONEAL DIALYSIS SETS | August 15, 1997 |