# K182144: Bi-Flex Evo

- Pathway: 510(k) (Special)
- Applicant: Promepla Sam
- Decided: Sep 7, 2018 after 30 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961904 (1996). 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)
- K140441: BI-Flex Ureteral Access Sheath, Promepla Sam (2014) Summary page 4.

## Indications for use
The BiFlex Evo is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids

Source page: https://510kreport.com/device/K182144
Methodology: https://510kreport.com/methodology