510(k) · Cleared
ClearedAmsure PVC Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · EZD Catheter, Straight
Cleared on Aug 21, 2009 as substantially equivalent to K030712 (Amsino International, Inc., 2003) after a 109-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Aug 21, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030712 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK030712 Amsure Urethral Catheterization TrayAmsino International, Inc. · 2003
- This deviceK091306 Amsure PVC Intermittent CatheterAmsino International, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK181445 AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030712 | Amsure Urethral Catheterization Tray | Amsino International, Inc. | 2003 | — |
| 0 (this device) | K091306 | Amsure PVC Intermittent Catheter | Amsino International, Inc. | 2009 | — |
| +1 | K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 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 |
|---|---|---|---|
| * | K030712 | Amsure Urethral Catheterization TraySummary page 1…Code: FCM Medical Specialty: Gastroenterology/Urology Device Class: Class II Unmodified Device: AMSure Tm Urethral Catheterization Tray (K03 0712) The AMSureTM PVC Intermittent Catheter is a sterile, single- use patient devic… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181445 | AMSure Hydrophilic Intermittent Catheter | 2018 | 0 |
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?
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The AMSure PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091306 · printed Nov 3, 2026
Cite this page
510(k) Report. “K091306: Amsure PVC Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K091306
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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