510(k) Report

510(k) · Cleared

Cleared

Hydrogel Coated Percuflex (R) Drainage Catheters

K924608510(k) TraditionalCleared Jan 26, 1994502-day reviewClass II21 CFR 876.5010

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

Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jan 26, 1994 after a 502-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Jan 26, 1994
Review
502 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
0

13 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2021: 2 descendants cleared2014: 1 descendant cleared2018: 3 descendants cleared2009: 1 descendant cleared2022: 1 descendant cleared2017: 2 descendants cleared2016: 2 descendants cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
  2. Descendant · cites it directly · 6 of its ownK141344 Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel…Boston Scientific Corp · 2014
  3. Descendant · cites it directly · 0 of its ownK211934 APDL Drainage Catheter System, Flexima APDL Drainage Catheter…Boston Scientific Corporation · 2022 · Recalled
  4. Descendant · cites it directly · 0 of its ownK200260 Percuflex Ureteral Stent System, Percuflex Ureteral Stent System…Boston Scientific Corporation · 2021
  5. Descendant · cites it directly · 0 of its ownK201436 Vortek Single Loop Ureteral StentColoplast Corp. · 2021
  6. Descendant · 2 generations on · 0 of its ownK183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009: 12014: 12016: 22017: 22018: 32019: 12021: 22022: 1
2009high 3 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all
  • K141344Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…Boston Scientific Corp · 2014 · cites it directly6descendants
  • K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…Boston Scientific Corporation · 2022 · cites it directly0descendants
  • K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex…Boston Scientific Corporation · 2021 · cites it directly0descendants
  • K201436Vortek Single Loop Ureteral StentColoplast Corp. · 2021 · cites it directly0descendants
  • K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924608Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp1994—
+1K141344Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral…Boston Scientific Corp2014—
+1K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima…Boston Scientific Corporation20225
+1K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit…Boston Scientific Corporation2021—
+1K201436Vortek Single Loop Ureteral StentColoplast Corp.2021—
+2K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
201620
201720
201830
201910
202120
202210
FIG. 1 — Lineage of K924608, 1994–2022Source: 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 FGE? 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 FGE device

  1. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K141344Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…Boston Scientific Corp20146
K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…Boston Scientific Corporation20220
K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex…Boston Scientific Corporation20210
K201436Vortek Single Loop Ureteral StentColoplast Corp.20210
K171603Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetCook Incorporated20180
K162109Kwart Retro-Inject Ureteral StentCook Incorporated20170
K160891Ultrathane Endoureterotomy Stent SetCook Incorporated20160
K090430Backstop and Backstop InjectorPluromed, Inc.20090

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, K141344 (Boston Scientific Corp, 2014) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

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

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

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https://510kreport.com/device/K924608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924608: Hydrogel Coated Percuflex (R) Drainage Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924608

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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