510(k) · Cleared
ClearedAll Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fortune Medical Instrument Corp. · EZL Catheter, Retention Type, Balloon
Cleared on Mar 31, 1998 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 31, 1998
- Review
- 20 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK980919 All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton CatheterFortune Medical Instrument Corp. · 1998
- Descendant · cites it directly · 1 of its ownK132890 Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013
- Descendant · cites it directly · 0 of its ownK190060 Urethrotech UCDUrethrotech · 2019
- Descendant · 2 generations on · 0 of its ownK182066 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK140099 Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K132890Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014 · cites it directly1descendant
- K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013 · cites it directly1descendant
- K190060Urethrotech UCDUrethrotech · 2019 · cites it directly0descendants
- K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018 · 2 generations on0descendants
- K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980919 | All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter | Fortune Medical Instrument Corp. | 1998 | — |
| +1 | K132890 | Suprapubic Catheter and Introducer Set | Mediplus, Ltd. | 2014 | — |
| +1 | K131655 | Lighthouse (TM) Urinary Catheter | Seedings Life Science Ventures, LLC | 2013 | — |
| +1 | K190060 | Urethrotech UCD | Urethrotech | 2019 | — |
| +2 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018 | — |
| +2 | K140099 | Lighthouse Urinary Catheter | Seedings Life Science Ventures, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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)
3 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, K132890 (Mediplus, Ltd., 2014) has gone furthest, with 1 descendant 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 Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980919
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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