510(k) · Cleared
ClearedSelf-Cath Closed System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on Aug 2, 2023 as substantially equivalent to K221401 (Coloplast, 2022) after a 224-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Aug 2, 2023
- Review
- 224 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003784 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FCM? 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 FCM device
- #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K221401 | Self-Cath and Self-Cath PlusSummary page 4…76.5130 Device Class: Class II Product Code FCM Review Panel: Gastroenterology/Urology Predicate Device: Self-Cath & Self-Cath Plus K221401 The predicate device has not been subject of a design related recall. Reference… | 2022 |
| † | K070939 | Self-Cath CS Closed Urinary Catheterization System | 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 22 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FCM devicesFCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FCM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCM
Too few FCM 510(k)s in any year since 2007 to give a median.
Recalls per year · FCM
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCM
35in 2025
MAUDE reports naming product code FCM, 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 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 31 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 61 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 85 |
| 2022 | 0 | — | 6 | 59 |
| 2023 | 1 | — | 1 (1) | 48 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Self-Cath Closed System is intended for use in male and female adult patients requiring bladder drainage as determined by their physician. The device is indicated for individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223821: Self-Cath Closed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223821
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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