510(k) · Cleared
ClearedFoley Balloon Catheter for Urology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollon Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Dec 30, 2020 as substantially equivalent to K130908 (Guangdong Baihe Medical Technology Co., Ltd., 2013) after a 184-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Dec 30, 2020
- Review
- 184 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896053 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 2 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- 1 generation backK130908 Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013
- This deviceK201776 Foley Balloon Catheter for UrologyApollon Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −2 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| −1 | K130908 | Disposable Silicone Foley Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K130908 | Disposable Silicone Foley CatheterSummary page 4…heter, Retention Type, Balloon Advisory Panel : Gastroenterology/Urology 3. Predicate Device 510(k) Number : K130908: Device Name : Disposable Silicone Foley Catheter Product Code : E… | 2013 |
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 30 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K130908.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way and Three-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201776 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201776: Foley Balloon Catheter for Urology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201776
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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