# K243371: Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

- Pathway: 510(k) (Traditional)
- Applicant: Byonyks Pvt, Ltd.
- Decided: May 16, 2025 after 198 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K923065 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181108: Fresenius Liberty Select Cycler, Fresenius Medical Care Renal Therapies Group, LLC (2018) Summary page 5.

## Indications for use
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.

Source page: https://510kreport.com/device/K243371
Methodology: https://510kreport.com/methodology