510(k) · Cleared
ClearedAmsure Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Oct 29, 2003 after a 289-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 29, 2003
- Review
- 289 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK030120 Amsure Foley CatheterAmsino International, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252537 Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
- Descendant · cites it directly · 0 of its ownK101824 Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009 · cites it directly4descendants
- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 2 generations on2descendants
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 3 generations on1descendant
- K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · 4 generations on0descendants
- K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030120 | Amsure Foley Catheter | Amsino International, Inc. | 2003 | — |
| +1 | K091699 | Amsure Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2009 | — |
| +2 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +3 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
| +4 | K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +1 | K101824 | Amsure 3-Way Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 EZL? 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 EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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, K091699 (Amsino International, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The AMSure Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030120: Amsure Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030120
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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