510(k) Report

510(k) · Cleared

Cleared

Rusch Intermittent Urethral Catheters

K173596510(k) TraditionalCleared Jan 29, 201869-day reviewClass II21 CFR 876.5130

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

Teleflex Medical · EZC Catheter, Coude

Cleared on Jan 29, 2018 after a 69-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Jan 29, 2018
Review
69 days
Class
Class II
Product code
EZC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2022: 1 descendant cleared201620182020202220242026
  1. This deviceK173596 Rusch Intermittent Urethral CathetersTeleflex Medical · 2018
  2. Descendant · cites it directly · 0 of its ownK222279 Rusch Intermittent Urethral CathetersTeleflex Medical · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K222279Rusch Intermittent Urethral CathetersTeleflex Medical · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K173596Rusch Intermittent Urethral CathetersTeleflex Medical2018—
+1K222279Rusch Intermittent Urethral CathetersTeleflex Medical2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K173596, 2018–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 EZC? 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 EZC device

  1. #1 K222279 Rusch Intermittent Urethral Cathetersscore 3.9 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K222279Rusch Intermittent Urethral CathetersTeleflex Medical20220

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, K222279 (Teleflex Medical, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EZC devices

EZC Catheter, Coude: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · EZC

1in 2022

2018: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZC

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

Recalls per year · EZC

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · EZC

1,213in 2025

2012: 12013: 32014: 142015: 202016: 1702017: 9632018: 8862019: 1,0002020: 1,0272021: 1,0302022: 1,3652023: 1,1422024: 9572025: 1,213
2007high 1,365 (2022) · low 0 (2007)2025

MAUDE reports naming product code EZC, 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—00
20090—00
20100—00
20110—00
20120—01
20130—03
20140—014
20150—020
20160—0170
20170—0963
20181—0886
20190—01,000
20200—01,027
20210—01,030
20221—01,365
20230—01,142
20240—0957
20250—01,213
20260—1—
Cite this page

510(k) Report. “K173596: Rusch Intermittent Urethral Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173596

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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