510(k) · Cleared
ClearedSpeedicath Compact Set (12 FR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · GBM Catheter, Urethral
Cleared on Oct 2, 2012 as substantially equivalent to K072808 (Coloplast Corp., 2007) after a 139-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 2, 2012
- Review
- 139 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). 4 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 deviceK121457 Speedicath Compact Set (12 FR)Coloplast Corp. · 2012
- Descendant · cites it directly · 2 of its ownK151772 Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK180801 Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK192904 SpeediCath Compact SetColoplast · 2020
- Descendant · 3 generations on · 0 of its ownK192577 Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. · 2016 · cites it directly2descendants
- K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc. · 2018 · 2 generations on1descendant
- K192904SpeediCath Compact SetColoplast · 2020 · cites it directly0descendants
- K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc. · 2020 · 3 generations on0descendants
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) | K121457 | Speedicath Compact Set (12 FR) | Coloplast Corp. | 2012 | — |
| +1 | K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016 | — |
| +2 | K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018 | — |
| +1 | K192904 | SpeediCath Compact Set | Coloplast | 2020 | — |
| +3 | K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 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 2…ieves the proposed Spoediath Compact Set is substantially equivalent in form and function to Coloplast's Speodiath Compact, which was cleared under 510O(k) K072808 on November 9, 2007. Speediath Compact Set and the predicate device are sterile, single use catheters for intermit… | 2007 |
| † | K973070 | Conveen Easicath Set | 1997 |
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 21 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K151772 (B.Braun Medical, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 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. 2012, 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?
Speediath Compact Set 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 device is intended for females only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121457: Speedicath Compact Set (12 FR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121457
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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