510(k) · Cleared
ClearedSpeediCath Flex Coude
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · GBM Catheter, Urethral
Cleared on Sep 29, 2016 as substantially equivalent to K023254 (Coloplast Corp., 2003) after a 112-day review. Its family tree reaches back 3 generations to 1991. 10 later devices descend from it.
- Decided
- Sep 29, 2016
- Review
- 112 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910022 (1991). 5 ancestors in all, the oldest K896750 (1990). 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 2 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 1 generation backK023254 SpeedicathColoplast Corp. · 2003
- This deviceK161672 SpeediCath Flex CoudeColoplast Corp. · 2016
- Descendant · cites it directly · 9 of its ownK180070 SpeediCath Flex Coude ProColoplast · 2018
- Descendant · 2 generations on · 8 of its ownK190620 SpeediCath Flex Coude ProColoplast · 2019
- Descendant · 3 generations on · 4 of its ownK230165 Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja…Coloplast · 2023
- Descendant · 4 generations on · 2 of its ownK241210 Luja CoudeColoplast Corp. · 2024
- Descendant · 3 generations on · 1 of its ownK200142 SpeediCath SoftColoplast · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180070SpeediCath Flex Coude ProColoplast · 2018 · cites it directly9descendants
- K190620SpeediCath Flex Coude ProColoplast · 2019 · 2 generations on8descendants
- K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…Coloplast · 2023 · 3 generations on4descendants
- K241210Luja CoudeColoplast Corp. · 2024 · 4 generations on2descendants
- K200142SpeediCath SoftColoplast · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −2 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| 0 (this device) | K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016 | — |
| +1 | K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018 | — |
| +2 | K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019 | — |
| +3 | K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111… | Coloplast | 2023 | — |
| +4 | K241210 | Luja Coude | Coloplast Corp. | 2024 | — |
| +3 | K200142 | SpeediCath Soft | Coloplast | 2020 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K023254 | SpeedicathSummary page 4…Class II Product code GBM Legally Marketed Predicate device Manufacturer predicate(s) K023254, SpeediCath Standard Coloplast A/S Reference device(s)… | 2003 |
| † | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084… | 2009 |
| † | K143594 | VaPro Pocket | 2015 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180070 | SpeediCath Flex Coude Pro | 2018 | 9 |
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 25 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180070 (Coloplast, 2018) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K023254.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The catheter is indicated for use by patients with 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 for male patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161672: SpeediCath Flex Coude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161672
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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