510(k) · Cleared
ClearedLuja Soft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A.S. · EZD Catheter, Straight
Cleared on Jul 7, 2026 as substantially equivalent to K200142 (Coloplast, 2020) after a 20-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 7, 2026
- Review
- 20 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K910022 (1991). 9 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 6 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 5 generations backK023254 SpeedicathColoplast Corp. · 2003
- 4 generations backK161672 SpeediCath Flex CoudeColoplast Corp. · 2016
- 3 generations backK180070 SpeediCath Flex Coude ProColoplast · 2018
- 2 generations backK190620 SpeediCath Flex Coude ProColoplast · 2019
- 1 generation backK200142 SpeediCath SoftColoplast · 2020
- This deviceK262045 Luja SoftColoplast A.S. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −6 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −5 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −4 | K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016 | — |
| −3 | K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018 | — |
| −2 | K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019 | — |
| −1 | K200142 | SpeediCath Soft | Coloplast | 2020 | — |
| 0 (this device) | K262045 | Luja Soft | Coloplast A.S. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 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?
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 35 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Soft 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/K262045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K262045: Luja Soft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K262045
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026