510(k) · Cleared
ClearedHydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Jimushi Meditech Co., Ltd. · EZD Catheter, Straight
Cleared on Jun 24, 2026 as substantially equivalent to K200134 (Hangzhou Jimushi Meditech Co., Ltd., 2020) after a 138-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 24, 2026
- Review
- 138 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000070 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK000070 FlocathRusch Intl. · 2000 · Recalled
- 2 generations backK183461 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG…Teleflexmedical, Inc. · 2019
- 1 generation backK200134 Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020
- This deviceK260394 Hydrophilic coated intermittent nalaton catheter for single…Hangzhou Jimushi Meditech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000070 | Flocath | Rusch Intl. | 2000 | 2 |
| −2 | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic… | Teleflexmedical, Inc. | 2019 | — |
| −1 | K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020 | — |
| 0 (this device) | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use… | Hangzhou Jimushi Meditech Co., Ltd. | 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 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 |
|---|---|---|---|
| * | K200134 | Jimushi Sterile Urethral Catheter for single useSummary page 5…name: Urological Catheter and accessories Regulation number: 21 CFR 876.5130 Product code: EZD Device Class: Class II 4. Identification of Predicate Device(s) K200134 Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated with water pocket model 5. Description of the Device Hydr… | 2020 |
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 26 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K200134.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
Intermittent urinary catheterization of adult males, females and pediatrics by inserting through the urethra to pass urine from the 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/K260394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260394: Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260394
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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