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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 a medical device manufactured by Byonyks Pvt, Ltd.. It received FDA 510(k) clearance on 2025-05-16 under approval 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. It is manufactured by Byonyks Pvt, Ltd.. The 510(k) number is K243371.

When was Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 approved by the FDA?

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

What company makes Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is manufactured by Byonyks Pvt, Ltd..

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.

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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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