510(k) Report

510(k) · Cleared

Cleared

Urinary Diversion Evacuating Catheter

K914692510(k) TraditionalCleared Jul 2, 1992258-day reviewClass II21 CFR 876.5895

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

Cook Urological, Inc. · EXD Irrigator, Ostomy

Cleared on Jul 2, 1992 after a 258-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 2, 1992
Review
258 days
Class
Class II
Product code
EXD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K914692Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All EXD devices

EXD Irrigator, Ostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXD

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EXD

Too few EXD 510(k)s in any year since 2007 to give a median.

Recalls per year · EXD

No recall names EXD since 2007.

Adverse event reports per year · EXD

1in 2021

2008: 22014: 22015: 32016: 12018: 302021: 1
2007high 30 (2018) · low 0 (2007)2025

MAUDE reports naming product code EXD, 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—00
20080—02
20090—00
20100—00
20110—00
20121—00
20130—00
20140—02
20150—03
20160—01
20170—00
20180—030
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
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 EXD

The EXD category page

  • K121833Ostomy Irrigation SetColoplast A/S · 2012
  • K904586Palex Irrigation SetPalex Intl. SA · 1990
  • K871791Bloxom IrrigatorI.B. Bloxom C/O Hogan & Hartson · 1987
  • K840268Irrigation SystemColoplast A/S · 1984
  • K832299Visi-Flow IrrigatorConvatec, A Division of E.R. Squibb & Sons · 1983

https://510kreport.com/device/K914692 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914692: Urinary Diversion Evacuating Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914692

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