# K905289: Surgitek (R) Lubri-Flex (TM) Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medical Engineering Corp.
- Decided: Mar 13, 1991 after 107 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
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961446: AQ Hydrophilic Stent (1996), 14 descendants of its own
- K151051: Universa Soft Ureteral Stents and Stent Sets (2016), 11 descendants of its own
- K161236: Universa Firm Ureteral Stents and Stent Sets (2017), 5 descendants of its own
- K213444: RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (2022), 2 descendants of its own
- K173734: RocaJJ Soft Stents (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K905289
Methodology: https://510kreport.com/methodology