510(k) · Cleared
ClearedSpeediCath Compact Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · GBM Catheter, Urethral
Cleared on Nov 2, 2020 as substantially equivalent to K121457 (Coloplast Corp., 2012) after a 384-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Nov 2, 2020
- Review
- 384 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910022 (1991). 7 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 4 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 3 generations backK023254 SpeedicathColoplast Corp. · 2003
- 2 generations backK072808 Speedicath CompactColoplast Corp. · 2007
- 1 generation backK121457 Speedicath Compact Set (12 FR)Coloplast Corp. · 2012
- This deviceK192904 SpeediCath Compact SetColoplast · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −4 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −3 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −2 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| −1 | K121457 | Speedicath Compact Set (12 FR) | Coloplast Corp. | 2012 | — |
| 0 (this device) | K192904 | SpeediCath Compact Set | Coloplast | 2020 | — |
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 |
|---|---|---|---|
| * | K121457 | Speedicath Compact Set (12 FR)Summary page 4…GBM (catheter, urethral) Review Panel: Gastroenterology/Urology Predicate Device: SpeediCath Compact Set, K121457 The predicate device has not been subject to a design related recall. This file contains… | 2012 |
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 29 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K121457.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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. This device is intended for females only.
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/K192904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192904: SpeediCath Compact Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192904
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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