FDA Product Code
FDA Product Code FKX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 83 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC | 2025-10-02 | Traditional | PDF ↗ |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App | Iren-Medical, Ltd. | 2022-12-29 | Traditional | PDF ↗ |
| K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 | Traditional | PDF ↗ |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 | Traditional | PDF ↗ |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | Cloudcath | 2022-02-09 | Traditional | PDF ↗ |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | Baxter Healthcare Corporation | 2020-11-19 | Traditional | PDF ↗ |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 | Special | PDF ↗ |
| K173718 | Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 | Traditional | PDF ↗ |
| K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 | Traditional | PDF ↗ |
| K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015-10-09 | Traditional | PDF ↗ |
| K141145 | LIBERTY PDX CYCLER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-07-30 | Traditional | PDF ↗ |
| K123630 | FRESENIUS LIBERTY CYCLER | Fresenius Medical Care North America, Design Cente | 2013-09-09 | Traditional | PDF ↗ |
| K124018 | AMIA AUTOMATED PD SYSTEM | Deka Research & Development Corp. | 2013-06-14 | Traditional | PDF ↗ |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | Deka Research & Development Corp. | 2011-07-29 | Traditional | PDF ↗ |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R | Baxter Healthcare Corp | 2011-03-30 | Traditional | PDF ↗ |
| K053512 | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 | Baxter Healthcare Corp | 2006-02-16 | Traditional | PDF ↗ |
| K043363 | FRESENIUS LIBERTY CYCLER | Fresenius Medical Care North America | 2005-03-31 | Traditional | PDF ↗ |
| K012988 | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 | Baxter Healthcare Corp | 2001-12-05 | Traditional | PDF ↗ |
| K002892 | FRSENIUS PD IQCARD CYCLER | Fresenius Medical Care North America | 2001-04-05 | Traditional | PDF ↗ |
| K994218 | EASY CARE AND TUBING SETS | Medionics International, Inc. | 2000-02-10 | Special | PDF ↗ |
| K935659 | BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST | Baxter Healthcare Corp | 1994-07-07 | Traditional | PDF ↗ |
| K923065 | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL | Baxter Healthcare Corp | 1994-03-04 | Traditional | PDF ↗ |
| K933687 | R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 | R & D Batteries, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K905809 | NMC CYCLER MACHINE | National Medical Care, Medical Products Div., Inc. | 1992-02-25 | Traditional | PDF ↗ |
| K910173 | SELECTRA AND TUBING SETS | Medionics International , Ltd. | 1992-01-13 | Traditional | PDF ↗ |
| K902149 | FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM | Fresenius/Delmed, Inc. | 1990-10-30 | Traditional | PDF ↗ |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | Delmed, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | Delmed, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901228 | MULTI-STRIP | Bellhouse Medical, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K895336 | ABBOTT INPERSOL CYCLER 1000 | Abbott Laboratories | 1989-11-28 | Traditional | PDF ↗ |
| K884554 | PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 | Baxter Healthcare Corp | 1989-01-31 | Traditional | PDF ↗ |
| K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Travenol Laboratories, S.A. | 1987-09-30 | Traditional | PDF ↗ |
| K862928 | AMUKIN-50% FOR CAPD Y-SET | Amuchina Intl., Inc. | 1987-03-09 | Traditional | PDF ↗ |
| K845042 | ABBOTT INPERSOL CYCLER 1000 | Abbott Laboratories | 1985-03-19 | Traditional | PDF ↗ |
| K844630 | ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM | Organon Teknika Corp. | 1985-03-12 | Traditional | PDF ↗ |
| K850406 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM | Travenol Laboratories, S.A. | 1985-02-21 | Traditional | PDF ↗ |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | Renal Systems, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K844144 | SCD STERILE CONNECTION DEVICE | E.I. Dupont DE Nemours & Co., Inc. | 1984-11-16 | Traditional | PDF ↗ |
| K842885 | EXTENDED LIFE CAPD SOLUTION TRANSFER | Travenol Laboratories, S.A. | 1984-10-18 | Traditional | PDF ↗ |
| K841929 | LIFEMED LIFECOIL CATHETERS | Lifemed of California | 1984-08-08 | Traditional | PDF ↗ |
| K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 | Medionics International , Ltd. | 1984-06-25 | Traditional | PDF ↗ |
| K840224 | EXTENDED LIFE CAPD SOLUTION TRANSFER | Travenol Laboratories, S.A. | 1984-02-21 | Traditional | PDF ↗ |
| K833749 | PERITONEAL CATHETER-CHANGES- | Quinton, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K833595 | CAPD ULTRAVIOLET GERMICIDAL EXCHANGE | Travenol Laboratories, S.A. | 1983-11-29 | Traditional | PDF ↗ |
| K833065 | AUTOMATIC PERITONEAL DIALYSIS CYCLER | Travenol Laboratories, S.A. | 1983-11-28 | Traditional | PDF ↗ |
| K831766 | MICROSTAR VCI | Medionics International , Ltd. | 1983-10-14 | Traditional | PDF ↗ |
| K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER | Medionics International , Ltd. | 1983-10-14 | Traditional | PDF ↗ |
| K831716 | CAPD - CATHETER ADAPTER | American Mcgaw | 1983-06-24 | Traditional | PDF ↗ |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | American Medical Products, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K830766 | ABBOTT PATIENT ASSIST DEVICE | Abbott Laboratories | 1983-03-29 | Traditional | PDF ↗ |
| K830689 | EMPTY DIALYSATE CONTAINER BB-69 | Delmed, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | American Medical Products, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830208 | BETA-CAP D ADAPTER | Quinton, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K830257 | NON-STERILE PERITONEAL ACCESS CATHET- | Evermed, Inc. | 1983-02-24 | Traditional | PDF ↗ |
| K823857 | IMPRA PERITONEAL CATHETER | Impra, Inc. | 1983-01-26 | Traditional | PDF ↗ |
| K823296 | PC-205 TENCKHOFF CATHETER ROD OBTURATOR | Medigroup | 1983-01-26 | Traditional | PDF ↗ |
| K823331 | PC-204 TUNNELOR | Medigroup | 1983-01-26 | Traditional | PDF ↗ |
| K823303 | QUILL CATHETER GUIDE | Medigroup | 1983-01-26 | Traditional | PDF ↗ |
| K823390 | PC 201A LOCKING SLEEVE | Medigroup | 1983-01-26 | Traditional | PDF ↗ |
| K823330 | DIALATORS PC-203 & 202 | Medigroup | 1983-01-26 | Traditional | PDF ↗ |
| K823777 | STERILE, DISPOS. SPIKE PROTECTOR-5C4138 | Travenol Laboratories, S.A. | 1983-01-07 | Traditional | PDF ↗ |
| K823217 | INPERSOL PERITONEAL DIALSIS CYCLER SET | Abbott Laboratories | 1982-11-30 | Traditional | PDF ↗ |
| K822712 | INPERSOL-CAPD ADMINIS. SET TYPE DP | Abbott Laboratories | 1982-10-21 | Traditional | PDF ↗ |
| K822658 | EXTENSION SET TYPE DP | Abbott Laboratories | 1982-10-21 | Traditional | PDF ↗ |
| K822550 | SAFE LOCK TITANIUM ADAPTER SET | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822543 | CAPD SAFE LOCK TRANSFER SET | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822546 | SAFE LOCK SEALING CAPS | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822549 | CCPD CYCLER SET W/5 PRONGED SAFE LOCK | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822544 | SAFE LOCK SEALING CAP L | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822548 | SAFE LOCK CATHETER S-3 | American Medical Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822025 | AUTOMATIC SPLICING DEVICE | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-09 | Traditional | PDF ↗ |
| K822547 | CAPD BELT | American Medical Products, Inc. | 1982-09-09 | Traditional | PDF ↗ |
| K822361 | DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 | Travenol Laboratories, S.A. | 1982-08-16 | Traditional | PDF ↗ |
| K820179 | ERIKA CAPD PREP KIT #30-9501-5 | Erika, Inc. | 1982-02-19 | Traditional | PDF ↗ |
| K813487 | CATHETER BUBBLE STAND | Accurate Surgical Instruments Co. | 1981-12-31 | Traditional | PDF ↗ |
| K811986 | THE AMP 80/2 PEDIATRIC CYCLER SYSTEM | American Medical Products, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K810683 | CAPD CATHETER ADAPTER | American Mcgaw | 1981-05-08 | Traditional | PDF ↗ |
| K791342 | ADR-10600(ADR 400),10601 (ADR 300) | Physio-Control Corp. | 1979-11-16 | Traditional | PDF ↗ |
| K772150 | DIALYSIS DRAINAGE UNIT, PERITONEAL | C.R. Bard, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K771484 | RINSE BLOCK ASSEM, D-W PERI. DIALYSIS | Quinton, Inc. | 1977-10-25 | Traditional | PDF ↗ |
Product code FKX · Class II · Gastroenterology, Urology. Data: openFDA.