Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371)
Description
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 by Byonyks Pvt, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243371
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therap... | 2018 |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, ... | Fresenius Medical Care Renal Therap... | 2018 |
Trace the full predicate network for K243371
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.