510(k) · Cleared
ClearedClassic Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical, Ltd. · EZD Catheter, Straight
Cleared on Oct 11, 2013 as substantially equivalent to K951260 (Biosearch Medical Products, Inc., 1995) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Oct 11, 2013
- Review
- 51 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003784 (2001). 3 ancestors in all, the oldest K951260 (1995). No later device cites it as a predicate yet.
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) | K132619 | Classic Intermittent Catheter | Flexicare Medical, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K951260 | Urinary Intermittent Catheters W/O Hydromer Hydrophilic LubricantSummary page 1…Class 2 Predicative Devices * BARD "lnterglide" which was cleared for marketing by 51 0(k) No K951260. * Coloplast "Self Cath" which was cleared for marketing by 510… | 1995 |
| * | K100878 | Self Cath CatheterSummary page 1…No K951260. * Coloplast "Self Cath" which was cleared for marketing by 510k No K100878 Description: Classicm Intermittent Catheter is a PVC plastic device that is… | 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 12 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K951260.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Classic' intermifttent catheters are Intended for use in Male, Female and Peedlatric patients when regular assisted bladder drainage has been instructed by.a physician.
Classlem Intermittent catheters are Indicated for use by indivduals whose ability to void the bladder fully by natural bodily functions Is Impaired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132619: Classic Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132619
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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