510(k) · Cleared
ClearedSpeediCath Compact Eve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · GBM Catheter, Urethral
Cleared on Jul 2, 2015 as substantially equivalent to K072808 (Coloplast Corp., 2007) after an 86-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jul 2, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910022 (1991). 6 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- 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 deviceK150935 SpeediCath Compact EveColoplast A/S · 2015
View 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) | K150935 | SpeediCath Compact Eve | Coloplast A/S | 2015 | — |
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 GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 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 5…eves the proposed SpeediCath Compact Eve is substantially equivalent in form and function to Coloplast’s SpeediCath Compact, which was cleared under 510(k) K072808 on November 9, 2007. SpeediCath Compact Eve and the predicate device are sterile, single use catheters for intermit… | 2007 |
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 24 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.
- 4 other devices also cite its predicate K072808.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
SpeediCath Compact Eve 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 catheter is for female patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150935: SpeediCath Compact Eve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150935
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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