510(k) · Cleared
ClearedAmsure Urethral Catheterization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on May 23, 2003 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK030712 Amsure Urethral Catheterization TrayAmsino International, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK091306 Amsure PVC Intermittent CatheterAmsino International, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK181445 AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK082831 Amself Closed Catheterization SystemAmsino International, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K091306Amsure PVC Intermittent CatheterAmsino International, Inc. · 2009 · cites it directly1descendant
- K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018 · 2 generations on0descendants
- K082831Amself Closed Catheterization SystemAmsino International, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030712 | Amsure Urethral Catheterization Tray | Amsino International, Inc. | 2003 | — |
| +1 | K091306 | Amsure PVC Intermittent Catheter | Amsino International, Inc. | 2009 | — |
| +2 | K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018 | — |
| +1 | K082831 | Amself Closed Catheterization System | Amsino International, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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?
- Of its descendants, K091306 (Amsino International, Inc., 2009) has gone furthest, with 1 descendant of its own.
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.
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?
The MSure Urethral Catherization Tray is intended for use in the drainage of urine from the bladder.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030712: Amsure Urethral Catheterization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030712
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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