510(k) Report

510(k) · Cleared

Cleared

Malecot-Nephrostomy Tamponade Catheter

K915209510(k) TraditionalCleared Nov 10, 1992358-day reviewClass U

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

Cook Urological, Inc. · LJE Catheter, Nephrostomy

Cleared on Nov 10, 1992 after a 358-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 10, 1992
Review
358 days
Class
Class U
Product code
LJE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared1990200020102020
  1. This deviceK915209 Malecot-Nephrostomy Tamponade CatheterCook Urological, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915209Malecot-Nephrostomy Tamponade CatheterCook Urological, Inc.1992—
+1K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K915209, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LJE? 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 LJE device

  1. #1 K250448 Disposable Percutaneous Nephrostomy Dilatation…score 9.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated20190

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?

  • Of its descendants, K183051 (Cook Incorporated, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LJE devices

LJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJE

1in 2025

2007: 12008: 12012: 12014: 12016: 12017: 12018: 32019: 42020: 22022: 12023: 12025: 1
2007high 4 (2019) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJE

254in 2019

2018: 107 days median2019: 254 days median
2007high 254 (2019) · low 107 (2018)2026

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

Recalls per year · LJE

1in 2025

2007: 12016: 12019: 12020: 22021: 12025: 1
2007high 2 (2020) · low 0 (2008)2026

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

Adverse event reports per year · LJE

59in 2025

2007: 52008: 82009: 122010: 62011: 152012: 162013: 152014: 42015: 92016: 262017: 602018: 692019: 782020: 502021: 382022: 422023: 1312024: 472025: 59
2007high 131 (2023) · low 4 (2014)2025

MAUDE reports naming product code LJE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—15
20081—08
20090—012
20100—06
20110—015
20121—016
20130—015
20141—04
20150—09
20161—126
20171—060
20183107069
20194254178
20202—250
20210—138
20221—042
20231—0131
20240—047
20251—159
20260—0—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in LJE

The LJE category page

  • K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd. · 2025
  • K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023
  • K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture…Coloplast Corp. · 2022
  • K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020
  • K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with…Cook Incorporated · 2020

https://510kreport.com/device/K915209 · printed Nov 4, 2026

Cite this page

510(k) Report. “K915209: Malecot-Nephrostomy Tamponade Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915209

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026