# K212868: JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

- Pathway: 510(k) (Traditional)
- Applicant: Rocamed Sam
- Decided: Jan 26, 2022 after 139 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903345 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030503: Modification to Contour Polaris Ureteral Stent, Boston Scientific Corp (2003) Summary page 5.
- K173734: RocaJJ Soft Stents, Promepla Sam (2018) Summary page 5.

## Indications for use
The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction. The stents may be placed using endoscopic techniques. The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days. Target population: adults only (greater than 21 years of age).

Source page: https://510kreport.com/device/K212868
Methodology: https://510kreport.com/methodology