510(k) · Cleared
ClearedAll-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sewoon Medical Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Feb 15, 2002 as substantially equivalent to K981612 (Rochester Medical Corp., 1998) after a 137-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 15, 2002
- Review
- 137 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896053 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 1 generation backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- This deviceK013276 All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK091767 3 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK181616 PSM 3-Way Silicone Foley CatheterPathway, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −1 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| 0 (this device) | K013276 | All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) | Sewoon Medical Co., Ltd. | 2002 | — |
| +1 | K091767 | 3 Way Silicone Foley Balloon Catheter | Cook Urological, Inc. | 2009 | — |
| +2 | K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…Summary page 1…Name: Urological Catheter 78 EZL Common/Usual Name: Foley Balloon Catheter 2. Equivalent legally marketed device: All Silicone Foley Catheters, Rochester Medical Corp. K981612. 3. Indications for Use (intended use) For Urological Use only. Two-Way Catheter: Urethral catheterization for bladder drainage.… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091767 | 3 Way Silicone Foley Balloon Catheter | 2009 | 1 |
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 12 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091767 (Cook Urological, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K981612.
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?
For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013276
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026