510(k) · Cleared
ClearedYikang Latex Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Yikang Medical Instrument Group Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Jul 13, 2018 as substantially equivalent to K071423 (Medline Industries, Inc., 2007) after a 263-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 13, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903777 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK903777 WRP FoleycathWembley Rubber Products (M) Sdn Bhd · 1990
- 1 generation backK071423 Medline Latex Foley CatheterMedline Industries, Inc. · 2007
- This deviceK173340 Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK232469 Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK262056 Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903777 | WRP Foleycath | Wembley Rubber Products (M) Sdn Bhd | 1990 | — |
| −1 | K071423 | Medline Latex Foley Catheter | Medline Industries, Inc. | 2007 | — |
| 0 (this device) | K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018 | — |
| +1 | K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024 | — |
| +2 | K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071423 | Medline Latex Foley CatheterSummary page 4…uct Code: EZL Regulation Number: 876.5130 Device Class: 2 Legally marketed predicate device to which substantial equivalence is claimed: e Medline Latex Foley Catheter, k071423 Device Description The YiKang Latex Foley Catheter is a flexible tubular device that is passed through the urethra into the bla… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | 2024 | 1 |
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 28 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232469 (Teleflexmedical, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071423.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 YiKang Latex Foley Catheter is intended to be placed in the bladder, through the urethra, to drain urine and other fluids from the urinary bladder.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173340: Yikang Latex 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/K173340
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