510(k) · Cleared

Cleared

Greene Renal Transplant Stent Set

K180557510(k) TraditionalCleared Nov 23, 2018267-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

Cleared on Nov 23, 2018 as substantially equivalent to K961446 (Cook Urological, Inc., 1996) after a 267-day review. Its family tree reaches back 2 generations to 1991.

Decided: Nov 23, 2018
Review: 267 days
Class: Class II
Product code: FAD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K905289 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK905289 Surgitek (R) Lubri-Flex (TM) Ureteral StentMedical Engineering Corp. · 1991
1 generation backK961446 AQ Hydrophilic StentCook Urological, Inc. · 1996 · Recalled
This deviceK180557 Greene Renal Transplant Stent SetCook Incorporated · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K905289	Surgitek (R) Lubri-Flex (TM) Ureteral Stent	Medical Engineering Corp.	1991	—
−1	K961446	AQ Hydrophilic Stent	Cook Urological, Inc.	1996	18
0 (this device)	K180557	Greene Renal Transplant Stent Set	Cook Incorporated	2018	—

FIG. 1 — Lineage of K180557, 1991–2018Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K961446	AQ Hydrophilic Stent Summary page 4 …lation: 21 CFR §876.4620 Product Code: FAD Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Devices:  K961446 AQ Hydrophilic Stent (Cook Urological). Device Description: The Greene Renal Transplant Stent Set is sterile, single-use device.…	Cook Urological, Inc.	1996	18

Also cleared against K961446: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 27 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K961446.

How does its category compare?

All FAD devices

FAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?

Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180557 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180557: Greene Renal Transplant Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180557

Report an extraction error

Are you the manufacturer?

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