510(k) · Cleared
Recalled · Class II · 2025Bard Inlayoptima Ureteral Stent with Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FAD Stent, Ureteral
Cleared on Dec 7, 2004 as substantially equivalent to K022447 (C.R. Bard, Inc., 2003) after a 19-day review. Its family tree reaches back 3 generations to 1991. 12 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 7, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903345 (1991). 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 2 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 1 generation backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- This deviceK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · cites it directly · 1 of its ownK173734 RocaJJ Soft StentsPromepla Sam · 2018
- Descendant · 2 generations on · 1 of its ownK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · cites it directly11descendants
- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · cites it directly5descendants
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · 2 generations on2descendants
- K173734RocaJJ Soft StentsPromepla Sam · 2018 · cites it directly1descendant
- K162104C-Flex Ureteral Stent SetCook Incorporated · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −2 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −1 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | — |
| +1 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| +1 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +2 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +1 | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
| +2 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022447 | Bard ER Ureteral Stent with SutureSummary page 1…Ureteral Stent C Predicate Device Name: Trade Name Bard' InLayOptima M Ureteral Stent with Suture #K022447 D. Device Description: The Bard; lnLayOptima T Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtail ure… | 2003 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2025 | Class II | Z-0906-2026 | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| Nov 6, 2025 | Class II | Z-0908-2026 | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| Nov 6, 2025 | Class II | Z-0905-2026 | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| Nov 6, 2025 | Class II | Z-0907-2026 | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| Oct 13, 2016 | Class II | Z-0406-2017 | Labeling Change Control | 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 Change Control | 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K151051 (Cook Incorporated, 2016) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K022447.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043193: Bard Inlayoptima Ureteral Stent with Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043193
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026