510(k) · Cleared
ClearedDynarex Intermittent Catheters, Male, Female, Pediatric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corporation · EZD Catheter, Straight
Cleared on Jun 7, 2011 as substantially equivalent to K100878 (Coloplast Manufacturing Us, LLC, 2010) after a 231-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jun 7, 2011
- Review
- 231 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003784 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K100878 | Self Cath CatheterSummary page 1…be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube. Predicate Device: Self Cath Catheter, 510(k) Number K100878, manufactured by Holtedam 1,3050 Humlebaek, Denmark Substantial Equivalence: The Dynarex Intermittent Catheter provides effective… | 2010 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- 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. 2011, 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 Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (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 who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103086: Dynarex Intermittent Catheters, Male, Female, Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103086
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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