510(k) · Cleared
Recalled · Class II · 2016Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to as Bard Lubricious Ureteral Ste
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 15, 1998 as substantially equivalent to K903345 (C.R. Bard, Inc., 1991) after a 71-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 15, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903345 (1991). 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- This deviceK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 11 of its ownK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- Descendant · 3 generations on · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · cites it directly · 3 of its ownK190312 Dornier Ureteral StentDornier Medtech America, Inc. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K022447Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003 · cites it directly14descendants
- K043193Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · 2 generations on12descendants
- K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · 3 generations on11descendants
- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · 3 generations on5descendants
- K190312Dornier Ureteral StentDornier Medtech America, Inc. · 2019 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| 0 (this device) | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | — |
| +1 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| +2 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| +3 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| +3 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +1 | K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K903345 | Bard (R) Lubricious - Coated Ureteral Stent SutureSummary page 2…al Characteristics Bard Lubricious Ureteral Stent Bard Lubricious-Coated Ureteral Difference Product Characteristic (this 510(k)) Stent with Suture (Predicate device) (#K903345) Stent Indications or Intended The Bard Lubricious Ureteral Stent is The Bard Lubricious-Coated Ureteral None Use indicated to re… | 1991 |
What descends from it? (16)
See all 162 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 |
|---|---|---|---|---|
| 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-0404-2017 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K022447 (C.R. Bard, Inc., 2003) has gone furthest, with 14 descendants of its own.
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 Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma 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.
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/K983498 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983498: Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to as Bard Lubricious Ureteral Ste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983498
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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