FKXFDA Class 2 · 21 CFR 876.5630
System, Peritoneal, Automatic Delivery
Device family · Gastroenterology, Urology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
83
Manufacturers
15
Flagged signals
13
Adverse-event reports
153,943
Code matrix
| FDA product code | FKX |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2019 | 3 | 56.8 | 114 |
| Death | 2019 | 5 | 43.7 | 169 |
| Death | 2014 | 6 | 37.8 | 182 |
| Death | 2014 | 14 | 18.7 | 219 |
| Other | 2013 | 51 | 9.4 | 375 |
| Death | 2010 | 7 | 5.2 | 20 |
| Death | 2010 | 3 | 4.0 | 4 |
| Death | 2009 | 3 | 4.0 | 4 |
| Other | 2012 | 19 | 3.5 | 32 |
| Death | 2014 | 111 | 3.5 | 197 |
| Injury | 2013 | 5 | 2.6 | 6 |
| Injury | 2017 | 9 | 2.6 | 12 |
| Injury | 2014 | 6 | 2.2 | 5 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 153,943 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Travenol Laboratories, S.A. | 8 | 1987 | — |
| Fresenius Medical Care Renal Therapies Group, LLC | 6 | 2022 | — |
| Abbott Laboratories | 6 | 1989 | — |
| Baxter Healthcare Corp | 6 | 2011 | — |
| Quinton, Inc. | 4 | 1987 | — |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1984 | — |
| Fresenius Medical Care North America | 2 | 2005 | — |
| R & D Batteries, Inc. | 1 | 1994 | — |
| Baxter Healthcare Corporation | 1 | 2020 | — |
| C.R. Bard, Inc. | 1 | 1977 | — |
| Erika, Inc. | 1 | 1982 | — |
| National Medical Care, Medical Products Div., Inc. | 1 | 1992 | — |
| Organon Teknika Corp. | 1 | 1985 | — |
| LIFEMED OF CALIFORNIA | 1 | 1984 | — |
| Physio-Control Corp. | 1 | 1979 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
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, LLC510(k) · 2025-10-02
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 · Byonyks Pvt, Ltd.510(k) · 2025-05-16
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App · Iren-Medical, Ltd.510(k) · 2022-12-29
Fresenius Liberty Select Cycler · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2022-10-31
Lilliput APD System · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2022-04-15
CloudCath Peritoneal Dialysis Drain Set Monitoring System · Cloudcath510(k) · 2022-02-09
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System · Baxter Healthcare Corporation510(k) · 2020-11-19
Fresenius Liberty Select Cycler · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2018-05-24
Liberty Cycler Set · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2018-05-01
Fresenius Liberty Select Cycler · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2017-09-15
Amia Automated PD System with Sharesource · Deka Research and Development510(k) · 2015-10-09
LIBERTY PDX CYCLER · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2014-07-30
FRESENIUS LIBERTY CYCLER · Fresenius Medical Care North America, Design Cente510(k) · 2013-09-09
AMIA AUTOMATED PD SYSTEM · Deka Research & Development Corp.510(k) · 2013-06-14
VOYAGER PERITONEAL DIALYSIS SYSTEM · Deka Research & Development Corp.510(k) · 2011-07-29
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R · Baxter Healthcare Corp510(k) · 2011-03-30
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 · Baxter Healthcare Corp510(k) · 2006-02-16
FRESENIUS LIBERTY CYCLER · Fresenius Medical Care North America510(k) · 2005-03-31
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 · Baxter Healthcare Corp510(k) · 2001-12-05
FRSENIUS PD IQCARD CYCLER · Fresenius Medical Care North America510(k) · 2001-04-05
EASY CARE AND TUBING SETS · Medionics International, Inc.510(k) · 2000-02-10
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST · Baxter Healthcare Corp510(k) · 1994-07-07
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL · Baxter Healthcare Corp510(k) · 1994-03-04
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 · R & D Batteries, Inc.510(k) · 1994-02-09
NMC CYCLER MACHINE · National Medical Care, Medical Products Div., Inc.510(k) · 1992-02-25
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.