510(k) · Cleared
ClearedSpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · EZD Catheter, Straight
Cleared on Mar 8, 2022 as substantially equivalent to K072808 (Coloplast Corp., 2007) after a 449-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 8, 2022
- Review
- 449 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910022 (1991). 6 ancestors in all, the oldest K896750 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 3 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 2 generations backK023254 SpeedicathColoplast Corp. · 2003
- 1 generation backK072808 Speedicath CompactColoplast Corp. · 2007
- This deviceK203637 SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact…Coloplast · 2022
- Descendant · cites it directly · 0 of its ownK241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead®…Well Lead Medical Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241028 Luja female (20051); Luja female (20052); Luja female (20054); Luja…Coloplast · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −3 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −2 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −1 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| 0 (this device) | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus… | Coloplast | 2022 | — |
| +1 | K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic… | Well Lead Medical Co., Ltd. | 2025 | — |
| +1 | K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female… | Coloplast | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K072808 | Speedicath CompactSummary page 4…0 Device Class II Panel Gastroenterology/Urology Product Code GBM 510(k) Number K072808 Page 1 of 4… | 2007 |
What descends from it? (2)
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 31 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K241734 (Well Lead Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K072808.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a 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 indicated for female patients only (adults and children of and above the age of 2 years). Choice of model and size of the catheter for the individual patient is made upon recommendation by the local health care professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203637: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203637
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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