510(k) · Cleared
ClearedMedline Latex Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Jul 18, 2007 as substantially equivalent to K903777 (Wembley Rubber Products (M) Sdn Bhd, 1990) after a 57-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903777 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903777 WRP FoleycathWembley Rubber Products (M) Sdn Bhd · 1990
- This deviceK071423 Medline Latex Foley CatheterMedline Industries, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK173340 Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK232469 Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK262056 Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
- Descendant · cites it directly · 0 of its ownK170233 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary…Zhanjiang Star Enterprise Co., Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K173340Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018 · cites it directly2descendants
- K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024 · 2 generations on1descendant
- K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026 · 3 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K903777 | WRP Foleycath | Wembley Rubber Products (M) Sdn Bhd | 1990 | — |
| 0 (this device) | K071423 | Medline Latex Foley Catheter | Medline Industries, Inc. | 2007 | — |
| +1 | K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018 | — |
| +2 | K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024 | — |
| +3 | K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +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 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K903777 | WRP FoleycathSummary page 2…ate Device Name Medfine Latex Foley Catheter Foleycath NR Latex Balloon Catheter (K903777) Intended Use The Medline Latex Foley The Foleycath is intended to be Catheter is i… | 1990 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K173340 (Jiangxi Yikang Medical Instrument Group Co., Ltd., 2018) has gone furthest, with 2 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. 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 Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071423: Medline Latex 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/K071423
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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