510(k) · Cleared

Cleared

Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System

K141344510(k) TraditionalCleared Oct 17, 2014148-day reviewClass II21 CFR 876.4620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · FAD Stent, Ureteral

Cleared on Oct 17, 2014 as substantially equivalent to K924608 (Boston Scientific Corp, 1994) after a 148-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Oct 17, 2014
Review: 148 days
Class: Class II
Product code: FAD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924608 (1994). 6 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
This deviceK141344 Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel…Boston Scientific Corp · 2014
Descendant · cites it directly · 0 of its ownK183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019
Descendant · cites it directly · 0 of its ownK180216 Seidmon Antegrade AQ Stent SetCook Incorporated · 2018
Descendant · cites it directly · 0 of its ownK180029 Malecot Nephrostomy Catheter/Stent SetCook Incorporated · 2018
Descendant · cites it directly · 0 of its ownK171603 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetCook Incorporated · 2018
Descendant · cites it directly · 0 of its ownK170010 Salle Intraoperative Pyeloplasty Stent SetCook Incorporated · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2016high 3 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all

K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019 · cites it directly0descendants
K180216Seidmon Antegrade AQ Stent SetCook Incorporated · 2018 · cites it directly0descendants
K180029Malecot Nephrostomy Catheter/Stent SetCook Incorporated · 2018 · cites it directly0descendants
K171603Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetCook Incorporated · 2018 · cites it directly0descendants
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
−1	K924608	Hydrogel Coated Percuflex (R) Drainage Catheters	Boston Scientific Corp	1994	—
0 (this device)	K141344	Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral…	Boston Scientific Corp	2014	—
+1	K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set	Cook Incorporated	2019	—
+1	K180216	Seidmon Antegrade AQ Stent Set	Cook Incorporated	2018	—
+1	K180029	Malecot Nephrostomy Catheter/Stent Set	Cook Incorporated	2018	—
+1	K171603	Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set	Cook Incorporated	2018	—
+1	K170010	Salle Intraoperative Pyeloplasty Stent Set	Cook Incorporated	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2018	3	0
2019	1	0

FIG. 1 — Lineage of K141344, 1994–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K924608	Hydrogel Coated Percuflex (R) Drainage Catheters Summary page 5 …Classification Panel: Gastroenterology/Urology Predicate Device Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent (K924608, 26-Jan-1994) Intended Use / Expel™ Nephroureteral Stent System with Twist-Loc™ Hub: Indications for Use…	Boston Scientific Corp	1994	—

Also cleared against K924608: 7 other devices →

What descends from it? (6)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set	Cook Incorporated	2019
K180216	Seidmon Antegrade AQ Stent Set	Cook Incorporated	2018
K180029	Malecot Nephrostomy Catheter/Stent Set	Cook Incorporated	2018
K171603	Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set	Cook Incorporated	2018
K170010	Salle Intraoperative Pyeloplasty Stent Set	Cook Incorporated	2017
K161277	ConvertX Nephroureteral Stent System	Brightwater Medical	2016

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?

Its one ancestor has no recall.
Of its descendants, K183051 (Cook Incorporated, 2019) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K924608.

How does its category compare?

All FAD devices

FAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FAD

4in 2025

2007high 9 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAD

186in 2025

2007high 266 (2017) · low 143 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FAD

4in 2025

2007high 22 (2008) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAD

634in 2025

2007high 691 (2023) · low 43 (2007)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 Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.

The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141344

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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