KDJ · Set, Administration, For Peritoneal Dialysis, Disposable
Gastroenterology, Urology · 21 CFR 876.5630 · Class 2
Overview
| Product Code | KDJ |
|---|---|
| Device Name | Set, Administration, For Peritoneal Dialysis, Disposable |
| Regulation | 21 CFR 876.5630 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
Classification Rationale
Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
Special Controls
*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
Cleared Devices (113)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Apr 3, 2025 | SESE |
| 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 | Mar 12, 2024 | SESE |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | Mar 18, 2022 | SESE |
| K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | Oct 25, 2019 | SESE |
| 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 | May 21, 2018 | SESE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | Feb 14, 2018 | SESE |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | Jan 24, 2018 | SESE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection System | Puracath Medical, Inc. | Jan 20, 2016 | SESE |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | Baxter Healthcare | Oct 29, 2015 | SESE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Baxter Healthcare Corporation | Oct 29, 2015 | SESE |
| K124024 | APD LUER-LOCK ADAPTER | Fresensius Medical Care North America | Sep 19, 2013 | SESE |
| K083542 | FRESENIUS STERILE STAY SAFE CAP | Fresenius Medical Care North America | Dec 29, 2008 | SESE |
| K042900 | K.E.P. CONNECTOR AND CLIP | K.E.P., LLC | Nov 5, 2004 | SESE |
| K041792 | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 | Fresenius Medical Care North America | Sep 24, 2004 | SESE |
| K031676 | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q | Baxter Healthcare Corp | Nov 20, 2003 | SESE |
| K022412 | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR | Fresenius Medical Care North America | Mar 5, 2003 | SESE |
| K974387 | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE | Microwave Medical Systems, Inc. | Sep 1, 1999 | SESE |
| K972579 | HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE | Baxter Healthcare Corp | Oct 1, 1997 | SESE |
| K972731 | NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET | Klein-Baker Medical, Inc. | Sep 29, 1997 | SESE |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | Medisystems Corp. | Aug 15, 1997 | SESE |
| K961825 | ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 | Baxter Healthcare Corp | Aug 6, 1996 | SESE |
| K945567 | QC CAP | Medionics International, Inc. | Feb 7, 1995 | SESE |
| K930843 | RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 | National Medical Care, Medical Products Div., Inc. | Aug 31, 1994 | SESE |
| K921818 | ABBOTT SMART CAP | Abbott Laboratories | Mar 28, 1994 | SESE |
| K925403 | BAXTER APD 12' EXTENSION LINE | Baxter Healthcare Corp | Feb 22, 1994 | SESE |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | Fresenius USA, Inc. | Feb 25, 1993 | SESE |
| K920586 | DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET | National Medical Care, Medical Products Div., Inc. | Sep 21, 1992 | SESE |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | National Medical Care, Medical Products Div., Inc. | Sep 21, 1992 | SESE |
| K915628 | DEXTROLYTE II PERITONEAL DIALYSIS PUMP | National Medical Care, Medical Products Div., Inc. | Mar 16, 1992 | SESE |
| K915304 | ABBOTT SMART CAP | Abbott Laboratories | Feb 19, 1992 | SESE |
| K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE | Fresenius USA, Inc. | Jul 24, 1991 | SESE |
| K904806 | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR | Fresenius USA, Inc. | Jan 11, 1991 | SESE |
| K900295 | PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES | Microwave Medical Systems, Inc. | Nov 21, 1990 | SESE |
| K903869 | 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET | Fresenius/Delmed, Inc. | Nov 20, 1990 | SESE |
| K902526 | CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481 | Baxter Healthcare Corp | Nov 20, 1990 | SESE |
| K902451 | LONG-LIFE Y-SET CAT. NO. 48-6366-8 | National Medical Care, Medical Products Div., Inc. | Aug 14, 1990 | SESE |
| K900106 | CLOSED DISCONNECT SYSTEM | Delmed, Inc. | Jul 16, 1990 | SESE |
| K895992 | CATHETER EXTENSION SET CAT. NO. 48-3027-9 | National Medical Care, Medical Products Div., Inc. | Mar 23, 1990 | SESE |
| K895792 | DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6 | National Medical Care, Medical Products Div., Inc. | Mar 23, 1990 | SESE |
| K900323 | PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900243 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900242 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900226 | DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900142 | DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900141 | DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900140 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900012 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900008 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K896600 | DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K896599 | DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K895991 | PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6 | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K895990 | DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | Mar 22, 1990 | SESE |
| K900005 | DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1 | National Medical Care, Medical Products Div., Inc. | Mar 2, 1990 | SESE |
| K900006 | CATHETER ADAPTER SEALING CAP NO. 48-1028-9 | National Medical Care, Medical Products Div., Inc. | Feb 27, 1990 | SESE |
| K900004 | CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3 | National Medical Care, Medical Products Div., Inc. | Feb 27, 1990 | SESE |
| K896956 | QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3 | National Medical Care, Medical Products Div., Inc. | Feb 27, 1990 | SESE |
| K896764 | UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 | National Medical Care, Medical Products Div., Inc. | Feb 26, 1990 | SESE |
| K896763 | CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1 | National Medical Care, Medical Products Div., Inc. | Feb 26, 1990 | SESE |
| K896761 | TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1 | National Medical Care, Medical Products Div., Inc. | Feb 26, 1990 | SESE |
| K895673 | CONNECTION SHIELDS CODES 5C4213 AND 5C4215 | Baxter Healthcare Corp | Jan 29, 1990 | SESE |
| K895631 | DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 | Baxter Healthcare Corp | Jan 29, 1990 | SESE |
| K894783 | PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP | Baxter Healthcare Corp | Sep 7, 1989 | SESE |
| K893712 | PERITONEAL DIALYSIS SYSTEM AND ACCESS. | Delmed, Inc. | Jul 24, 1989 | SESE |
| K893231 | DELCLAMP | Delmed, Inc. | Jun 8, 1989 | SESE |
| K892872 | PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | May 18, 1989 | SESE |
| K892871 | PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | May 18, 1989 | SESE |
| K892870 | PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD | National Medical Care, Medical Products Div., Inc. | May 18, 1989 | SESE |
| K883393 | CAPD DISPOSABLE Y SYSTEM - DY SET | Medionics International , Ltd. | Nov 3, 1988 | SESE |
| K883239 | CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS | Baxter Healthcare Corp | Oct 21, 1988 | SESE |
| K882498 | EXTENDED LIFE CAPD TRANSFER SET 5C4444 | Baxter Healthcare Corp | Jul 13, 1988 | SESE |
| K882455 | EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 | Baxter Healthcare Corp | Jul 13, 1988 | SESE |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Travenol Laboratories, S.A. | Oct 20, 1987 | SESE |
| K871155 | DELFLEX RIGID DRAIN CONTAINER | Delmed, Inc. | Jul 16, 1987 | SESE |
| K871583 | MODIFIED LABELING FOR AMUKIN-50% | Amuchina Intl., Inc. | Jul 9, 1987 | SESE |
| K870626 | FREEDOM SET II WITH TRIFLEX VALVE | Delmed, Inc. | Jun 3, 1987 | SESE |
| K871154 | DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE | Delmed, Inc. | Apr 30, 1987 | SESE |
| K871050 | CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM. | Abbott Laboratories | Apr 10, 1987 | SESE |
| K871049 | CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN. | Abbott Laboratories | Apr 10, 1987 | SESE |
| K870145 | EXTERNAL Y VALVE 5C4198 | Travenol Laboratories, S.A. | Mar 10, 1987 | SESE |
| K860700 | CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 | Travenol Laboratories, S.A. | Apr 7, 1986 | SESE |
| K860230 | CAPD TRANSFER SET SPIKE 5C4363 | Travenol Laboratories, S.A. | Feb 5, 1986 | SESE |
| K853550 | TRAVENOL CAPD Y SET 5C4354 | Travenol Laboratories, S.A. | Oct 4, 1985 | SESE |
| K852678 | CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 | Travenol Laboratories, S.A. | Jul 29, 1985 | SESE |
| K851208 | COMPACT EXCHANGE DEVICE 5C4197 | Travenol Laboratories, S.A. | Apr 8, 1985 | SESE |
| K851207 | EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 | Travenol Laboratories, S.A. | Apr 8, 1985 | SESE |
| K820546 | CARD U.V. GERMICIDAL CHAMBER II | Travenol Laboratories, S.A. | Jun 30, 1982 | SESE |
| K812802 | CAPD U.V. GERMICIDAL CONNECTION SYSTEM | Travenol Laboratories, S.A. | Mar 2, 1982 | SESE |
| K813069 | PERITONEAL DIALYSIS CYCLER SET | American Medical Products, Inc. | Nov 16, 1981 | SESE |
| K812772 | PERITONEAL DIALYSIS CYCLER SET (8UNIT) | Dravon Medical, Inc. | Oct 19, 1981 | SESE |
| K812771 | PERITONEAL DIALYSIS DRAINAGE | Dravon Medical, Inc. | Oct 19, 1981 | SESE |
| K811863 | STERI-TRACT | Rogo Ent. | Sep 21, 1981 | SESE |
| K812130 | SPIKE GUARD | Clinipad Corp. | Sep 9, 1981 | SESE |
| K811294 | GAMBRO PERITONEAL DIALYSIS FLUID LINES | Gambro, Inc. | Jun 12, 1981 | SESE |
| K810840 | AMP PERITONEAL DIALYSIS PREP KIT | American Medical Products, Inc. | Apr 29, 1981 | SESE |
| K810671 | CCPD 3 LITER DRAINAGE SET | American Medical Products, Inc. | Mar 24, 1981 | SESE |
| K810670 | CCPD CYCLER SET | American Medical Products, Inc. | Mar 24, 1981 | SESE |
| K810600 | CAPD EXCHANGE SET | American Mcgaw | Mar 24, 1981 | SESE |
| K803300 | INPERSOL CAPD BAG PORT CLAMP | Abbott Laboratories | Jan 29, 1981 | SESE |
| K801881 | INPERSOL-CAPD ADMINISTRATION SET | Abbott Laboratories | Oct 10, 1980 | SESE |
| K801220 | PERITONEAL DIALYSIS CYCLER SET W/PUMP | American Medical Products, Inc. | Aug 12, 1980 | SESE |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Aug 12, 1980 | SESE |
| K800993 | INPERSOL CAPD ADMIN. SET & CATHETER ADAP | Abbott Laboratories | Aug 12, 1980 | SESE |
| K792651 | CAPD TRANSFER SET JC9044 | Travenol Laboratories, S.A. | Feb 6, 1980 | SESE |
| K791512 | CONTINUOUS AMBULATORY DIALYSIS (CAPD) | Norton Performance Plastics Corp. | Feb 6, 1980 | SESE |
| K791722 | DISPOSABLE PERITONEAL DIALYSIS EXTENSION | American Medical Products, Inc. | Nov 16, 1979 | SESE |
| K791899 | CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 | Travenol Laboratories, S.A. | Nov 13, 1979 | SESE |
| K791426 | PERITONEAL PAC | Intermed, Inc. | Aug 28, 1979 | SESE |
| K781755 | DAP-PAK | Dravon Medical, Inc. | Feb 15, 1979 | SESE |
| K780957 | SET, ADMINISTRATION, MANUAL, DIALYSIS | American Medical Products, Inc. | Jul 6, 1978 | SESE |
| K780082 | PERITONEAL DIALYSIS ADMIN. SET | Physio-Control Corp. | Jan 24, 1978 | SESE |
| K772236 | FILTER, PERITONEAL DIALY. ADMIN. SET | Millipore Corp. | Jan 24, 1978 | SESE |
| K771482 | RINSE BLOCK CONNECTOR | Quinton, Inc. | Jan 3, 1978 | SESE |
| K772136 | PERITONEAL CYCLER & MANIFOLD SET | Physio-Control Corp. | Dec 20, 1977 | SESE |
Top Applicants
- National Medical Care, Medical Products Div., Inc. — 30 clearances
- Travenol Laboratories, S.A. — 12 clearances
- Baxter Healthcare Corp — 11 clearances
- American Medical Products, Inc. — 7 clearances
- Abbott Laboratories — 7 clearances
