510(k) · Cleared
ClearedSelf-Cath CS Closed Urinary Catheterization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Manufacturing Us, LLC · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on Jun 1, 2007 as substantially equivalent to K003873 (Mentor Corp., 2001) after a 58-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 1, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003873 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003873 Mentor Self-Cath Closed SystemMentor Corp. · 2001
- This deviceK070939 Self-Cath CS Closed Urinary Catheterization SystemColoplast Manufacturing Us, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003873 | Mentor Self-Cath Closed System | Mentor Corp. | 2001 | — |
| 0 (this device) | K070939 | Self-Cath CS Closed Urinary Catheterization System | Coloplast Manufacturing Us, LLC | 2007 | — |
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
- #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 |
|---|---|---|---|
| * | K003873 | Mentor Self-Cath Closed SystemSummary page 2…loplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit. The SCCS is intended to be used to drain urine from the bladder. The SCCS… | 2001 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K003873.
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. 2007, 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® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070939 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070939: Self-Cath CS Closed Urinary Catheterization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070939
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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