# K043193: Bard Inlayoptima Ureteral Stent with Suture

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 7, 2004 after 19 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903345 (1991). 3 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022447: Bard ER Ureteral Stent with Suture, C.R. Bard, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K162104: C-Flex Ureteral Stent Set (2017), 1 descendant of its own

## Recalls of this device
- Nov 6, 2025 · Class II · Z-0906-2026: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Nov 6, 2025 · Class II · Z-0908-2026: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Nov 6, 2025 · Class II · Z-0905-2026: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Nov 6, 2025 · Class II · Z-0907-2026: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Oct 13, 2016 · Class II · Z-0406-2017: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
- Oct 13, 2016 · Class II · Z-0405-2017: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

## Indications for use
The Bard® InlayOptima T M Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

Source page: https://510kreport.com/device/K043193
Methodology: https://510kreport.com/methodology