# K243039: Ureteral Stents (AF-D series)

- Pathway: 510(k) (Traditional)
- Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
- Decided: Jun 18, 2025 after 264 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: 5 generations back to K903345 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151051: Universa Soft Ureteral Stents and Stent Sets, Cook Incorporated (2016) Summary page 5.

## Indications for use
Ureteral Stents (AF-D series) are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral Stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The indwelling time should not exceed 30 days.

Source page: https://510kreport.com/device/K243039
Methodology: https://510kreport.com/methodology