510(k) · Cleared
ClearedBard ER 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 Jan 23, 2003 as substantially equivalent to K983498 (C.R. Bard, Inc., 1998) after a 181-day review. Its family tree reaches back 2 generations to 1991. 14 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 181 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903345 (1991). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 1 generation backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- This deviceK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 11 of its ownK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · 2 generations on · 1 of its ownK173734 RocaJJ Soft StentsPromepla Sam · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K043193Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · cites it directly12descendants
- K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · 2 generations on11descendants
- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · 2 generations on5descendants
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · 3 generations on2descendants
- K173734RocaJJ Soft StentsPromepla Sam · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −1 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| 0 (this device) | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| +1 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| +2 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| +2 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +3 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +2 | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to…Summary page 2…eristics Product Characteyistics Bard® inlay Dptima™ Urcteral Stent {this 510(k)) Bard (nLoy Lubriclous Double Platail Ureteral Stant with Suture (Predicate device - #K983498) Difference Stent The Bard® Inlay Optima™ Ureteral Stent Tha Bard Lubricious Ureteral Stent Minimal edRtorial Indicattens o… | 1998 |
What descends from it? (14)
See all 142 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 7.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K043193 (C.R. Bard, Inc., 2004) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K983498.
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® Inlay Optima™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022447 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022447: Bard ER Ureteral Stent with Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022447
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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