510(k) · Cleared
ClearedJimushi Sterile Urethral Catheter for single use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Jimushi Meditech Co., Ltd. · GBM Catheter, Urethral
Cleared on Jun 1, 2020 as substantially equivalent to K183461 (Teleflexmedical, Inc., 2019) after a 132-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 1, 2020
- Review
- 132 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000070 (2000). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000070 FlocathRusch Intl. · 2000 · Recalled
- 1 generation backK183461 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG…Teleflexmedical, Inc. · 2019
- This deviceK200134 Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK260394 Hydrophilic coated intermittent nalaton catheter for single…Hangzhou Jimushi Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243175 Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222677 Intermittent nelaton catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd. · 2026 · cites it directly0descendants
- K243175Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd. · 2025 · cites it directly0descendants
- K222677Intermittent nelaton catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000070 | Flocath | Rusch Intl. | 2000 | 2 |
| −1 | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic… | Teleflexmedical, Inc. | 2019 | — |
| 0 (this device) | K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020 | — |
| +1 | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use… | Hangzhou Jimushi Meditech Co., Ltd. | 2026 | — |
| +1 | K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025 | — |
| +1 | K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 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 |
|---|---|---|---|
| * | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…Summary page 4…ame: Urological catheter and accessories Regulation number: 21 CFR 876.5130 Product code: GBM Device Class: Class II 4. Identification of Predicate Device(s) K183461 Teleflex Medical Rusch FloCath Quick Urological Catheter 5. Description of the Device Jimushi Sterile Urethral Catheter for si… | 2019 |
What descends from it? (3)
3 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 19.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K260394 (Hangzhou Jimushi Meditech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183461.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200134: Jimushi Sterile Urethral Catheter for single use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200134
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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