510(k) · Cleared
ClearedSunmed Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmed, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Jun 4, 2007 as substantially equivalent to K980870 (Rusch, Inc., 1998) after a 315-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 4, 2007
- Review
- 315 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980870 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980870 Rusch Silicone Foley CatheterRusch, Inc. · 1998
- This deviceK062112 Sunmed Foley CathetersSunmed, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980870 | Rusch Silicone Foley Catheter | Rusch, Inc. | 1998 | — |
| 0 (this device) | K062112 | Sunmed Foley Catheters | Sunmed, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K980870 | Rusch Silicone Foley CatheterSummary page 1…icated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr. Predicate Device: Rusch Silicon Coated Foley Catheter - K980870 Substantial Equivalence: SunMed claims the proposed device to be substantially equivalent to the device previously cleared by F… | 1998 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K980870.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062112: Sunmed Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062112
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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