510(k) · Cleared
ClearedDisposable Silicone Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Baihe Medical Technology Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Oct 3, 2013 as substantially equivalent to K981612 (Rochester Medical Corp., 1998) after a 185-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896053 (1990). 6 later devices descend from it, 6 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 deviceK130908 Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK201776 Foley Balloon Catheter for UrologyApollon Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK182463 Silicone Foley CatheterBiosensors International Pte, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK172807 Silicone Foley Catheter for single useChangzhou Rongxin Medicine Minimal Invasion Technology · 2018
- Descendant · cites it directly · 0 of its ownK172278 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK170233 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary…Zhanjiang Star Enterprise Co., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201776Foley Balloon Catheter for UrologyApollon Co., Ltd. · 2020 · cites it directly0descendants
- K182463Silicone Foley CatheterBiosensors International Pte, Ltd. · 2019 · cites it directly0descendants
- K172807Silicone Foley Catheter for single useChangzhou Rongxin Medicine Minimal Invasion Technology · 2018 · cites it directly0descendants
- K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated · 2017 · cites it directly0descendants
- K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…Zhanjiang Star Enterprise Co., Ltd. · 2017 · cites it directly0descendants
View 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) | K130908 | Disposable Silicone Foley Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 2013 | — |
| +1 | K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020 | — |
| +1 | K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | 2019 | — |
| +1 | K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018 | — |
| +1 | K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | 2017 | — |
| +1 | K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter… | Zhanjiang Star Enterprise Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 2…r irrigation for urological use only; the indwell timec ol the pioposed device is nw imor thiun 30l da. 5. Predicate Device Identification 510(k) Number: K981612 Product Name: Rochester Medical Corporation All Silicone Foley Catheter Manufacturer: Rochester Medical Corporation 6… | 1998 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201776 | Foley Balloon Catheter for Urology | 2020 | 0 |
| K182463 | Silicone Foley Catheter | 2019 | 0 |
| K172807 | Silicone Foley Catheter for single use | 2018 | 0 |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | 2017 | 0 |
| K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex… | 2017 | 0 |
| K161770 | Rusch Silicone Foley Catheter | 2017 | 0 |
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 23 years and passes through 2 companies; a new generation was cleared every 15.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201776 (Apollon Co., Ltd., 2020) has gone furthest, with 0 descendants 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. 2013, 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 Disposable Silicone Foley Catheter Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days.
Three-way Disposable Silicone Foley Catheter Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130908: Disposable 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/K130908
Report an extraction error
Are you the manufacturer?
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