FDA Product Code
FDA Product Code KDJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 113 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 | Traditional | PDF ↗ |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare | 2024-03-12 | Traditional | PDF ↗ |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | 2022-03-18 | Traditional | PDF ↗ |
| K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | 2019-10-25 | Special | PDF ↗ |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 | Traditional | PDF ↗ |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-14 | Traditional | PDF ↗ |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 | Traditional | PDF ↗ |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection System | Puracath Medical, Inc. | 2016-01-20 | Traditional | PDF ↗ |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Baxter Healthcare Corporation | 2015-10-29 | Traditional | PDF ↗ |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | Baxter Healthcare | 2015-10-29 | Traditional | PDF ↗ |
| K124024 | APD LUER-LOCK ADAPTER | Fresensius Medical Care North America | 2013-09-19 | Traditional | PDF ↗ |
| K083542 | FRESENIUS STERILE STAY SAFE CAP | Fresenius Medical Care North America | 2008-12-29 | Traditional | PDF ↗ |
| K042900 | K.E.P. CONNECTOR AND CLIP | K.E.P., LLC | 2004-11-05 | Traditional | PDF ↗ |
| K041792 | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 | Fresenius Medical Care North America | 2004-09-24 | Traditional | PDF ↗ |
| K031676 | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q | Baxter Healthcare Corp | 2003-11-20 | Traditional | PDF ↗ |
| K022412 | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR | Fresenius Medical Care North America | 2003-03-05 | Traditional | PDF ↗ |
| K974387 | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE | Microwave Medical Systems, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K972579 | HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE | Baxter Healthcare Corp | 1997-10-01 | Traditional | PDF ↗ |
| K972731 | NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET | Klein-Baker Medical, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | Medisystems Corp. | 1997-08-15 | Traditional | PDF ↗ |
| K961825 | ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 | Baxter Healthcare Corp | 1996-08-06 | Traditional | PDF ↗ |
| K945567 | QC CAP | Medionics International, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K930843 | RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 | National Medical Care, Medical Products Div., Inc. | 1994-08-31 | Traditional | PDF ↗ |
| K921818 | ABBOTT SMART CAP | Abbott Laboratories | 1994-03-28 | Traditional | PDF ↗ |
| K925403 | BAXTER APD 12' EXTENSION LINE | Baxter Healthcare Corp | 1994-02-22 | Traditional | PDF ↗ |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | Fresenius USA, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K920586 | DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K915628 | DEXTROLYTE II PERITONEAL DIALYSIS PUMP | National Medical Care, Medical Products Div., Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K915304 | ABBOTT SMART CAP | Abbott Laboratories | 1992-02-19 | Traditional | PDF ↗ |
| K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE | Fresenius USA, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K904806 | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR | Fresenius USA, Inc. | 1991-01-11 | Traditional | PDF ↗ |
| K900295 | PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES | Microwave Medical Systems, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K902526 | CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481 | Baxter Healthcare Corp | 1990-11-20 | Traditional | PDF ↗ |
| K903869 | 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET | Fresenius/Delmed, Inc. | 1990-11-20 | Traditional | PDF ↗ |
| K902451 | LONG-LIFE Y-SET CAT. NO. 48-6366-8 | National Medical Care, Medical Products Div., Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K900106 | CLOSED DISCONNECT SYSTEM | Delmed, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K895792 | DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6 | National Medical Care, Medical Products Div., Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K895992 | CATHETER EXTENSION SET CAT. NO. 48-3027-9 | National Medical Care, Medical Products Div., Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K900008 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900142 | DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900323 | PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900140 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900141 | DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K895991 | PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K895990 | DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900012 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900242 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K896600 | DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900243 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K896599 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900226 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6 | National Medical Care, Medical Products Div., Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900005 | DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1 | National Medical Care, Medical Products Div., Inc. | 1990-03-02 | Traditional | PDF ↗ |
| K900006 | CATHETER ADAPTER SEALING CAP NO. 48-1028-9 | National Medical Care, Medical Products Div., Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K900004 | CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3 | National Medical Care, Medical Products Div., Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896956 | QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3 | National Medical Care, Medical Products Div., Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896764 | UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 | National Medical Care, Medical Products Div., Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K896761 | TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1 | National Medical Care, Medical Products Div., Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K896763 | CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1 | National Medical Care, Medical Products Div., Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K895631 | DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 | Baxter Healthcare Corp | 1990-01-29 | Traditional | PDF ↗ |
| K895673 | CONNECTION SHIELDS CODES 5C4213 AND 5C4215 | Baxter Healthcare Corp | 1990-01-29 | Traditional | PDF ↗ |
| K894783 | PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP | Baxter Healthcare Corp | 1989-09-07 | Traditional | PDF ↗ |
| K893712 | PERITONEAL DIALYSIS SYSTEM AND ACCESS. | Delmed, Inc. | 1989-07-24 | Traditional | PDF ↗ |
| K893231 | DELCLAMP | Delmed, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K892872 | PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | 1989-05-18 | Traditional | PDF ↗ |
| K892871 | PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | 1989-05-18 | Traditional | PDF ↗ |
| K892870 | PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | 1989-05-18 | Traditional | PDF ↗ |
| K883393 | CAPD DISPOSABLE Y SYSTEM - DY SET | Medionics International , Ltd. | 1988-11-03 | Traditional | PDF ↗ |
| K883239 | CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS | Baxter Healthcare Corp | 1988-10-21 | Traditional | PDF ↗ |
| K882498 | EXTENDED LIFE CAPD TRANSFER SET 5C4444 | Baxter Healthcare Corp | 1988-07-13 | Traditional | PDF ↗ |
| K882455 | EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 | Baxter Healthcare Corp | 1988-07-13 | Traditional | PDF ↗ |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Travenol Laboratories, S.A. | 1987-10-20 | Traditional | PDF ↗ |
| K871155 | DELFLEX RIGID DRAIN CONTAINER | Delmed, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K871583 | MODIFIED LABELING FOR AMUKIN-50% | Amuchina Intl., Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K870626 | FREEDOM SET II WITH TRIFLEX VALVE | Delmed, Inc. | 1987-06-03 | Traditional | PDF ↗ |
| K871154 | DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE | Delmed, Inc. | 1987-04-30 | Traditional | PDF ↗ |
| K871049 | CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN. | Abbott Laboratories | 1987-04-10 | Traditional | PDF ↗ |
| K871050 | CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM. | Abbott Laboratories | 1987-04-10 | Traditional | PDF ↗ |
| K870145 | EXTERNAL Y VALVE 5C4198 | Travenol Laboratories, S.A. | 1987-03-10 | Traditional | PDF ↗ |
| K860700 | CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 | Travenol Laboratories, S.A. | 1986-04-07 | Traditional | PDF ↗ |
| K860230 | CAPD TRANSFER SET SPIKE 5C4363 | Travenol Laboratories, S.A. | 1986-02-05 | Traditional | PDF ↗ |
| K853550 | TRAVENOL CAPD Y SET 5C4354 | Travenol Laboratories, S.A. | 1985-10-04 | Traditional | PDF ↗ |
| K852678 | CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 | Travenol Laboratories, S.A. | 1985-07-29 | Traditional | PDF ↗ |
| K851207 | EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 | Travenol Laboratories, S.A. | 1985-04-08 | Traditional | PDF ↗ |
| K851208 | COMPACT EXCHANGE DEVICE 5C4197 | Travenol Laboratories, S.A. | 1985-04-08 | Traditional | PDF ↗ |
| K820546 | CARD U.V. GERMICIDAL CHAMBER II | Travenol Laboratories, S.A. | 1982-06-30 | Traditional | PDF ↗ |
| K812802 | CAPD U.V. GERMICIDAL CONNECTION SYSTEM | Travenol Laboratories, S.A. | 1982-03-02 | Traditional | PDF ↗ |
| K813069 | PERITONEAL DIALYSIS CYCLER SET | American Medical Products, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812772 | PERITONEAL DIALYSIS CYCLER SET (8UNIT) | Dravon Medical, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K812771 | PERITONEAL DIALYSIS DRAINAGE | Dravon Medical, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K811863 | STERI-TRACT | Rogo Ent. | 1981-09-21 | Traditional | PDF ↗ |
| K812130 | SPIKE GUARD | Clinipad Corp. | 1981-09-09 | Traditional | PDF ↗ |
| K811294 | GAMBRO PERITONEAL DIALYSIS FLUID LINES | Gambro, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K810840 | AMP PERITONEAL DIALYSIS PREP KIT | American Medical Products, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810671 | CCPD 3 LITER DRAINAGE SET | American Medical Products, Inc. | 1981-03-24 | Traditional | PDF ↗ |
| K810670 | CCPD CYCLER SET | American Medical Products, Inc. | 1981-03-24 | Traditional | PDF ↗ |
| K810600 | CAPD EXCHANGE SET | American Mcgaw | 1981-03-24 | Traditional | PDF ↗ |
| K803300 | INPERSOL CAPD BAG PORT CLAMP | Abbott Laboratories | 1981-01-29 | Traditional | PDF ↗ |
| K801881 | INPERSOL-CAPD ADMINISTRATION SET | Abbott Laboratories | 1980-10-10 | Traditional | PDF ↗ |
| K801220 | PERITONEAL DIALYSIS CYCLER SET W/PUMP | American Medical Products, Inc. | 1980-08-12 | Traditional | PDF ↗ |
Product code KDJ · Class II · Gastroenterology, Urology. Data: openFDA.