510(k) · Cleared
ClearedPSM 3-Way Silicone Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathway, LLC · EZL Catheter, Retention Type, Balloon
Cleared on Sep 21, 2018 as substantially equivalent to K091767 (Cook Urological, Inc., 2009) after a 94-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Sep 21, 2018
- Review
- 94 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896053 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 3 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- 2 generations backK013276 All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002
- 1 generation backK091767 3 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
- This deviceK181616 PSM 3-Way Silicone Foley CatheterPathway, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −3 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K091767 | 3 Way Silicone Foley Balloon CatheterSummary page 4…876.5130 October 9, EZL K091767 (MFG: Cook) Urological catheter and accessories 2009 Device D… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
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/K181616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181616: PSM 3-Way Silicone 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/K181616
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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