510(k) · Cleared
ClearedRusch Latex Gold Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical Sdn. Bhd. · EZL Catheter, Retention Type, Balloon
Cleared on Aug 5, 2026 as substantially equivalent to K232469 (Teleflexmedical, Inc., 2024) after a 48-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 5, 2026
- Review
- 48 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903777 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK903777 WRP FoleycathWembley Rubber Products (M) Sdn Bhd · 1990
- 3 generations backK071423 Medline Latex Foley CatheterMedline Industries, Inc. · 2007
- 2 generations backK173340 Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018
- 1 generation backK232469 Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024
- This deviceK262056 Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903777 | WRP Foleycath | Wembley Rubber Products (M) Sdn Bhd | 1990 | — |
| −3 | K071423 | Medline Latex Foley Catheter | Medline Industries, Inc. | 2007 | — |
| −2 | K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018 | — |
| −1 | K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024 | — |
| 0 (this device) | K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026 | — |
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 |
|---|---|---|---|
| * | K232469 | Rüsch Latex Gold Foley CatheterSummary page 5…Gastroenterology/Urology E. Predicate Device This submission demonstrates substantial equivalence to the predicate device, Rusch Latex Gold Foley Catheter, K232469. The predicate device has not been subjected to design-related recall. F. Device Description The Rüsch Latex Gold Foley C… | 2024 |
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 36 years and passes through 5 companies; a new generation was cleared every 11.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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. Catheters are indicated for use in male and female adults and pediatric…
Read the full statement (109 words)
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.
Catheters are indicated for use in male and female adults and pediatric patients with the following pediatric subgroups:
Children (2 years old to less than 12 years old),
Adolescents (12 years old to less than 18 years old), and
Transitional Adolescents (18 years old to less than 22 years old but treated like an adult).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262056: Rusch Latex Gold 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/K262056
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026