510(k) · Cleared
Recalled · 2008Pediatric Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · FAD Stent, Ureteral
Cleared on Mar 29, 2006 after a 15-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Mar 29, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 6
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK060673 Pediatric Ureteral StentApplied Medical Resources Corp. · 2006
- Descendant · cites it directly · 0 of its ownK170010 Salle Intraoperative Pyeloplasty Stent SetCook Incorporated · 2017
Most influential descendants
Showing 1 of 1 · See all- K170010Salle Intraoperative Pyeloplasty Stent SetCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060673 | Pediatric Ureteral Stent | Applied Medical Resources Corp. | 2006 | — |
| +1 | K170010 | Salle Intraoperative Pyeloplasty Stent Set | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | — | Cook Sot-Flex Pediatric Double Pigtail Stent Named without a submission number | |
| * | — | Applied Medical Ureteral Stent Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170010 | Salle Intraoperative Pyeloplasty Stent Set | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2008 | Not classified | Z-2224-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| May 20, 2008 | Not classified | Z-2219-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| May 20, 2008 | Not classified | Z-2222-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| May 20, 2008 | Not classified | Z-2220-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| May 20, 2008 | Not classified | Z-2223-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| May 20, 2008 | Not classified | Z-2221-2008 | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
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?
- Of its descendants, K170010 (Cook Incorporated, 2017) has gone furthest, with 0 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 Applied Medical Pediatric Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, with carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL) in patients 2 years of age and older. The stent is…
Read the full statement (156 words)
The Applied Medical Pediatric Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, with carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL) in patients 2 years of age and older. The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.
The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060673: Pediatric Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060673
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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