510(k) · Cleared
ClearedRusch Intermittent Urethral Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · EZC Catheter, Coude
Cleared on Aug 29, 2022 as substantially equivalent to K173596 (Teleflex Medical, 2018) after a 31-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Aug 29, 2022
- Review
- 31 days
- Class
- Class II
- Product code
- EZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K173596 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK173596 Rusch Intermittent Urethral CathetersTeleflex Medical · 2018
- This deviceK222279 Rusch Intermittent Urethral CathetersTeleflex Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K173596 | Rusch Intermittent Urethral Catheters | Teleflex Medical | 2018 | — |
| 0 (this device) | K222279 | Rusch Intermittent Urethral Catheters | Teleflex Medical | 2022 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173596 | Rusch Intermittent Urethral CathetersSummary page 4…Review Panel: Gastroenterology/Urology III. PREDICATE DEVICES Rusch Intermittent Urethral Catheters cleared in submission K173596 IV. DEVICE DESCRIPTION The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as t… | 2018 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All EZC devicesEZC Catheter, Coude: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EZC
1in 2022
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZC
1,213in 2025
MAUDE reports naming product code EZC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 170 |
| 2017 | 0 | — | 0 | 963 |
| 2018 | 1 | — | 0 | 886 |
| 2019 | 0 | — | 0 | 1,000 |
| 2020 | 0 | — | 0 | 1,027 |
| 2021 | 0 | — | 0 | 1,030 |
| 2022 | 1 | — | 0 | 1,365 |
| 2023 | 0 | — | 0 | 1,142 |
| 2024 | 0 | — | 0 | 957 |
| 2025 | 0 | — | 0 | 1,213 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222279: Rusch Intermittent Urethral Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222279
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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