Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKX — Predicate Candidate Screening
83 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
223 days90th percentile
83clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00 | Simergent, LLC | 2025-10-02 | 223 | 0 |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | 2025-05-16 | 198 | 0 |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (ID | Iren-Medical, Ltd. | 2022-12-29 | 273 | 0 |
| K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 | 90 | 1 |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 | 247 | 0 |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | Cloudcath | 2022-02-09 | 170 | 0 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platf | Baxter Healthcare Corporation | 2020-11-19 | 135 | 2 |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 | 27 | 0 |
| K173718 | Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 | 147 | 0 |
| K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 | 102 | 0 |
| K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015-10-09 | 123 | 1 |
| K141145 | LIBERTY PDX CYCLER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-07-30 | 89 | 0 |
| K123630 | FRESENIUS LIBERTY CYCLER | Fresenius Medical Care North America, Design Cente | 2013-09-09 | 290 | 1 |
| K124018 | AMIA AUTOMATED PD SYSTEM | Deka Research & Development Corp. | 2013-06-14 | 169 | 1 |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | Deka Research & Development Corp. | 2011-07-29 | 270 | 0 |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONE | Baxter Healthcare Corp | 2011-03-30 | 177 | 7 |
| K053512 | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSI | Baxter Healthcare Corp | 2006-02-16 | 62 | 3 |
| K043363 | FRESENIUS LIBERTY CYCLER | Fresenius Medical Care North America | 2005-03-31 | 114 | 8 |
| K012988 | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODEL | Baxter Healthcare Corp | 2001-12-05 | 90 | 9 |
| K002892 | FRSENIUS PD IQCARD CYCLER | Fresenius Medical Care North America | 2001-04-05 | 202 | 1 |
| K994218 | EASY CARE AND TUBING SETS | Medionics International, Inc. | 2000-02-10 | 57 | 0 |
| K935659 | BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST | Baxter Healthcare Corp | 1994-07-07 | 225 | 0 |
| K923065 | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL | Baxter Healthcare Corp | 1994-03-04 | 617 | 4 |
| K933687 | R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 | R & D Batteries, Inc. | 1994-02-09 | 195 | 0 |
| K905809 | NMC CYCLER MACHINE | National Medical Care, Medical Products Div., Inc. | 1992-02-25 | 425 | 0 |
| K910173 | SELECTRA AND TUBING SETS | Medionics International , Ltd. | 1992-01-13 | 363 | 0 |
| K902149 | FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM | Fresenius/Delmed, Inc. | 1990-10-30 | 168 | 0 |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | Delmed, Inc. | 1990-07-27 | 122 | 0 |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | Delmed, Inc. | 1990-07-27 | 122 | 0 |
| K901228 | MULTI-STRIP | Bellhouse Medical, Inc. | 1990-05-07 | 54 | 0 |
| K895336 | ABBOTT INPERSOL CYCLER 1000 | Abbott Laboratories | 1989-11-28 | 89 | 0 |
| K884554 | PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 | Baxter Healthcare Corp | 1989-01-31 | 92 | 0 |
| K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-12-29 | 50 | 0 |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Travenol Laboratories, S.A. | 1987-09-30 | 85 | 0 |
| K862928 | AMUKIN-50% FOR CAPD Y-SET | Amuchina Intl., Inc. | 1987-03-09 | 220 | 0 |
| K845042 | ABBOTT INPERSOL CYCLER 1000 | Abbott Laboratories | 1985-03-19 | 81 | 0 |
| K844630 | ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM | Organon Teknika Corp. | 1985-03-12 | 105 | 0 |
| K850406 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM | Travenol Laboratories, S.A. | 1985-02-21 | 17 | 0 |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | Renal Systems, Inc. | 1985-01-07 | 76 | 0 |
| K844144 | SCD STERILE CONNECTION DEVICE | E.I. Dupont DE Nemours & Co., Inc. | 1984-11-16 | 24 | 0 |
| K842885 | EXTENDED LIFE CAPD SOLUTION TRANSFER | Travenol Laboratories, S.A. | 1984-10-18 | 87 | 0 |
| K841929 | LIFEMED LIFECOIL CATHETERS | Lifemed of California | 1984-08-08 | 90 | 0 |
| K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 | Medionics International , Ltd. | 1984-06-25 | 13 | 0 |
| K840224 | EXTENDED LIFE CAPD SOLUTION TRANSFER | Travenol Laboratories, S.A. | 1984-02-21 | 33 | 0 |
| K833749 | PERITONEAL CATHETER-CHANGES- | Quinton, Inc. | 1983-12-27 | 62 | 0 |
| K833595 | CAPD ULTRAVIOLET GERMICIDAL EXCHANGE | Travenol Laboratories, S.A. | 1983-11-29 | 48 | 0 |
| K833065 | AUTOMATIC PERITONEAL DIALYSIS CYCLER | Travenol Laboratories, S.A. | 1983-11-28 | 81 | 0 |
| K831766 | MICROSTAR VCI | Medionics International , Ltd. | 1983-10-14 | 135 | 0 |
| K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER | Medionics International , Ltd. | 1983-10-14 | 101 | 0 |
| K831716 | CAPD - CATHETER ADAPTER | American Mcgaw | 1983-06-24 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda