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FDA 510(k)

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

K-Number: K243371 · 2025-05-16

ApplicantByonyks Pvt, Ltd.
Decision Date2025-05-16
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Byonyks Pvt, Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243371. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Byonyks Pvt, Ltd.. The 510(k) number is K243371.

When did Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 receive FDA 510(k) clearance?

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243371.

Who is the listed applicant for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

The FDA 510(k) record lists Byonyks Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

The FDA product code for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is FKX.

Related Devices (Code: FKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcathK201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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