510(k) · Cleared
ClearedSelf Cath Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Manufacturing Us, LLC · EZD Catheter, Straight
Cleared on May 26, 2010 as substantially equivalent to K003784 (Mentor Corp., 2001) after a 57-day review. Its family tree reaches back 1 generation to 2001. 13 later devices descend from it.
- Decided
- May 26, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003784 (2001). 13 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK003784 Mentor Self-Cath PlusMentor Corp. · 2001
- This deviceK100878 Self Cath CatheterColoplast Manufacturing Us, LLC · 2010
- Descendant · cites it directly · 3 of its ownK133470 Bard Ritecath Intermittent CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK142575 Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK140945 Compactcath Intermittent Urinary CatheterCompactcath, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK221401 Self-Cath and Self-Cath PlusColoplast · 2022
- Descendant · 2 generations on · 1 of its ownK160858 CompactCath Intermittent Urinary CatheterCompactcath, Inc. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K133470Bard Ritecath Intermittent CatheterC.R. Bard, Inc. · 2014 · cites it directly3descendants
- K142575Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc. · 2014 · cites it directly2descendants
- K140945Compactcath Intermittent Urinary CatheterCompactcath, Inc. · 2014 · cites it directly2descendants
- K221401Self-Cath and Self-Cath PlusColoplast · 2022 · cites it directly1descendant
- K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003784 | Mentor Self-Cath Plus | Mentor Corp. | 2001 | — |
| 0 (this device) | K100878 | Self Cath Catheter | Coloplast Manufacturing Us, LLC | 2010 | — |
| +1 | K133470 | Bard Ritecath Intermittent Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K142575 | Bard RiteCath Intermittent Urinary Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K140945 | Compactcath Intermittent Urinary Catheter | Compactcath, Inc. | 2014 | — |
| +1 | K221401 | Self-Cath and Self-Cath Plus | Coloplast | 2022 | — |
| +2 | K160858 | CompactCath Intermittent Urinary Catheter | Compactcath, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003784 | Mentor Self-Cath PlusSummary page 1…ly equivalent in performndnce, indicatiois,.clesign and materials to MtW Cath Pius cleared~on March 5, 2001' under premarket notific-ation 5 10(k) number K003784. L I..~ ~ ~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~7 Description of the Device: The Sell Cath Cath… | 2001 |
What descends from it? (13)
See all 138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133470 | Bard Ritecath Intermittent Catheter | 2014 | 3 |
| K142575 | Bard RiteCath Intermittent Urinary Catheter | 2014 | 2 |
| K140945 | Compactcath Intermittent Urinary Catheter | 2014 | 2 |
| K221401 | Self-Cath and Self-Cath Plus | 2022 | 1 |
| K140953 | Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter | 2014 | 1 |
| K172924 | GentleCath Intermittent Urinary Catheter | 2017 | 0 |
| K132619 | Classic Intermittent Catheter | 2013 | 0 |
| K103086 | Dynarex Intermittent Catheters, Male, Female, Pediatric | 2011 | 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?
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is 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 as stated in the FDA summary.
https://510kreport.com/device/K100878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100878: Self Cath Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100878
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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