FDA.reportPublic FDA data

510(k) K243371

Device
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
Applicant
Byonyks Pvt, Ltd.
510(k) number
K243371
Product code
FKX
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-16
Date received
2024-10-30
Regulation
876.5630
Classification name
System, Peritoneal, Automatic Delivery
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Eric Flachbart
Address
45/A Xx Block Khayban-E-Iqbal Phase Iii Dha Lahore PK 54000 54000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FKX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250523Archimedes 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, LLC2025-10-02
K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.2022-12-29
K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2022-10-31
K212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC2022-04-15
K212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath2022-02-09
K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation2020-11-19
K181108Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2018-05-24
K173718Liberty Cycler SetFresenius Medical Care Renal Therapies Group, LLC2018-05-01
K171652Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2017-09-15
K151525Amia Automated PD System with SharesourceDeka Research and Development2015-10-09
K141145LIBERTY PDX CYCLERFresenius Medical Care Renal Therapies Group, LLC2014-07-30
K123630FRESENIUS LIBERTY CYCLERFresenius Medical Care North America, Design Cente2013-09-09
K124018AMIA AUTOMATED PD SYSTEMDeka Research & Development Corp.2013-06-14
K103220VOYAGER PERITONEAL DIALYSIS SYSTEMDeka Research & Development Corp.2011-07-29
K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RBaxter Healthcare Corp2011-03-30