510(k) · Cleared
ClearedLuja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · EZD Catheter, Straight
Cleared on Aug 25, 2023 as substantially equivalent to K190620 (Coloplast, 2019) after a 217-day review. Its family tree reaches back 6 generations to 1991. 4 later devices descend from it.
- Decided
- Aug 25, 2023
- Review
- 217 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910022 (1991). 8 ancestors in all, the oldest K896750 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 5 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 4 generations backK023254 SpeedicathColoplast Corp. · 2003
- 3 generations backK161672 SpeediCath Flex CoudeColoplast Corp. · 2016
- 2 generations backK180070 SpeediCath Flex Coude ProColoplast · 2018
- 1 generation backK190620 SpeediCath Flex Coude ProColoplast · 2019
- This deviceK230165 Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja…Coloplast · 2023
- Descendant · cites it directly · 2 of its ownK241210 Luja CoudeColoplast Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK251116 Luja CoudéColoplast Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK250270 Luja SetColoplast Corp. · 2025
- Descendant · cites it directly · 0 of its ownK233101 Luja Coude (20108 Male CH18 - large packaging)Coloplast Corp. · 2023
Most influential descendants
Showing 4 of 4 · See all- K241210Luja CoudeColoplast Corp. · 2024 · cites it directly2descendants
- K251116Luja CoudéColoplast Corp. · 2025 · 2 generations on0descendants
- K250270Luja SetColoplast Corp. · 2025 · 2 generations on0descendants
- K233101Luja Coude (20108 Male CH18 - large packaging)Coloplast Corp. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −5 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −4 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −3 | K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016 | — |
| −2 | K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018 | — |
| −1 | K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019 | — |
| 0 (this device) | K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111… | Coloplast | 2023 | — |
| +1 | K241210 | Luja Coude | Coloplast Corp. | 2024 | — |
| +2 | K251116 | Luja Coudé | Coloplast Corp. | 2025 | — |
| +2 | K250270 | Luja Set | Coloplast Corp. | 2025 | — |
| +1 | K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K241210 (Coloplast Corp., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K190620.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for adult male patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230165: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230165
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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