510(k) · Cleared
ClearedRüsch Latex Gold Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Aug 1, 2024 as substantially equivalent to K173340 (Jiangxi Yikang Medical Instrument Group Co., Ltd., 2018) after a 352-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Aug 1, 2024
- Review
- 352 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903777 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK903777 WRP FoleycathWembley Rubber Products (M) Sdn Bhd · 1990
- 2 generations backK071423 Medline Latex Foley CatheterMedline Industries, Inc. · 2007
- 1 generation backK173340 Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018
- This deviceK232469 Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262056 Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903777 | WRP Foleycath | Wembley Rubber Products (M) Sdn Bhd | 1990 | — |
| −2 | K071423 | Medline Latex Foley Catheter | Medline Industries, Inc. | 2007 | — |
| −1 | K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018 | — |
| 0 (this device) | K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024 | — |
| +1 | K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K173340 | Yikang Latex Foley CatheterSummary page 4…EZL (Catheter, Retention Type, Balloon) Panel: Gastroenterology/Urology 3. PREDICATE DEVICE K173340, YiKang Latex Foley Catheter IDENTIFICATION The predicate device was never subjected to a design related recall. 4. DEV… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262056 | Rusch Latex Gold Foley Catheter | 2026 | 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 34 years and passes through 4 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K262056 (Teleflex Medical Sdn. Bhd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232469: Rüsch Latex Gold Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232469
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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