510(k) Report

510(k) · Cleared

Cleared

Accent DG Balloon Ureteral Dilator Set

K905375510(k) TraditionalCleared Apr 12, 1991133-day reviewClass II21 CFR 876.5470

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

Cook Urological, Inc. · EZN Dilator, Catheter, Ureteral

Cleared on Apr 12, 1991 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 12, 1991
Review
133 days
Class
Class II
Product code
EZN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared1990200020102020
  1. This deviceK905375 Accent DG Balloon Ureteral Dilator SetCook Urological, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK040127 Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K040127Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905375Accent DG Balloon Ureteral Dilator SetCook Urological, Inc.1991—
+1K040127Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K905375, 1991–2004Source: 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 EZN? 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 EZN device

  1. #1 K250910 Optilume® High Pressure Urological Balloon…score 10.0 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (1)

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

NumberDeviceApplicantDecidedDescendants
K040127Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc.20040

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, K040127 (Cook Urological, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EZN devices

EZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZN

1in 2025

2013: 22017: 12018: 42019: 12020: 12023: 12025: 1
2007high 4 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZN

175in 2018

2018: 175 days median
2007high 175 (2018)2026

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

Recalls per year · EZN

9in 2007

2007: 9
2007high 9 (2007) · low 0 (2008)2026

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

Adverse event reports per year · EZN

79in 2025

2007: 232008: 532009: 1242010: 522011: 542012: 382013: 272014: 282015: 302016: 192017: 652018: 582019: 562020: 402021: 412022: 512023: 832024: 492025: 79
2007high 124 (2009) · low 19 (2016)2025

MAUDE reports naming product code EZN, 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
20070—923
20080—053
20090—0124
20100—052
20110—054
20120—038
20132—027
20140—028
20150—030
20160—019
20171—065
20184175058
20191—056
20201—040
20210—041
20220—051
20231—083
20240—049
20251—079
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 EZN

The EZN category page

  • K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025
  • K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA…Allwin Medical Devices, Inc. · 2023
  • K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp. · 2020
  • K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019
  • K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated · 2018

https://510kreport.com/device/K905375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905375: Accent DG Balloon Ureteral Dilator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905375

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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