510(k) · Cleared
ClearedAmsure Hydrophilic Latex 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 Aug 10, 2009 as substantially equivalent to K030120 (Amsino International, Inc., 2003) and 3 other predicates after a 61-day review. Its family tree reaches back 2 generations to 1999. 4 later devices descend from it.
- Decided
- Aug 10, 2009
- Review
- 61 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K984084 (1999). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
- 1 generation backK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · Recalled
- This deviceK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
- Descendant · 3 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 4 of 4 · See all- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · cites it directly2descendants
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 2 generations on1descendant
- K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · 3 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 |
|---|---|---|---|---|---|
| −2 | K984084 | Bardex Lubri-Sil Foley Catheter | Bard Medical Div. | 1999 | 1 |
| −1 | K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR | C.R. Bard, Inc. | 2007 | 1 |
| 0 (this device) | K091699 | Amsure Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2009 | — |
| +1 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +2 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
| +3 | K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +1 | K101824 | Amsure 3-Way Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K030120 | Amsure Foley CatheterSummary page 1…mber: 876.5130 Class: 11 Classification Product Code: 78 EZL Predicate Devices: AMSURE' FOLEY CATHETER (k030120) BARDEX I.C. Latex Foley Catheter (k040658) BARDEX LUBRI-Sil All Silicon Lubricious Coated Foley Catheters (k070508) BARDEX LUBRI… | 2003 |
| * | K040658 | Bardex I.C. Latex Foley CatheterSummary page 1…11 Classification Product Code: 78 EZL Predicate Devices: AMSURE' FOLEY CATHETER (k030120) BARDEX I.C. Latex Foley Catheter (k040658) BARDEX LUBRI-Sil All Silicon Lubricious Coated Foley Catheters (k070508) BARDEX LUBRI-Sil Foley Catheters (k984084) Intended us… | 2004 |
| * | K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRSummary page 1…Predicate Devices: AMSURE' FOLEY CATHETER (k030120) BARDEX I.C. Latex Foley Catheter (k040658) BARDEX LUBRI-Sil All Silicon Lubricious Coated Foley Catheters (k070508) BARDEX LUBRI-Sil Foley Catheters (k984084) Intended use of the Device: The AMSURE eHYDROPHILIC LATEX FOLEY CATHETER, is intend… | 2007 |
| * | K984084 | Bardex Lubri-Sil Foley CatheterSummary page 1…(k030120) BARDEX I.C. Latex Foley Catheter (k040658) BARDEX LUBRI-Sil All Silicon Lubricious Coated Foley Catheters (k070508) BARDEX LUBRI-Sil Foley Catheters (k984084) Intended use of the Device: The AMSURE eHYDROPHILIC LATEX FOLEY CATHETER, is intended for use in the drainage of fluids from,… | 1999 |
What descends from it? (4)
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K162989 (Teleflexmedical, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K030120.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 AMSUREeHYDROPHILIC LATEX FOLEY CATHETER, is intendedfor use in the drainage offluids from, and to the urinary tract/bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091699: Amsure Hydrophilic Latex 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/K091699
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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