510(k) · Cleared
ClearedSelf-Cath and Self-Cath Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · EZD Catheter, Straight
Cleared on Dec 2, 2022 as substantially equivalent to K100878 (Coloplast Manufacturing Us, LLC, 2010) after a 200-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Dec 2, 2022
- Review
- 200 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003784 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003784 Mentor Self-Cath PlusMentor Corp. · 2001
- 1 generation backK100878 Self Cath CatheterColoplast Manufacturing Us, LLC · 2010
- This deviceK221401 Self-Cath and Self-Cath PlusColoplast · 2022
- Descendant · cites it directly · 0 of its ownK223821 Self-Cath Closed SystemColoplast · 2023
Most influential descendants
Showing 1 of 1 · See all- K223821Self-Cath Closed SystemColoplast · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003784 | Mentor Self-Cath Plus | Mentor Corp. | 2001 | — |
| −1 | K100878 | Self Cath Catheter | Coloplast Manufacturing Us, LLC | 2010 | — |
| 0 (this device) | K221401 | Self-Cath and Self-Cath Plus | Coloplast | 2022 | — |
| +1 | K223821 | Self-Cath Closed System | Coloplast | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223821 | Self-Cath Closed System | 2023 | 0 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223821 (Coloplast, 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K100878.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
Self-Cath and Self-Cath Plus are intended for use in male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
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/K221401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221401: Self-Cath and Self-Cath Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221401
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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