510(k) · Decided
DecidedRusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GBM Catheter, Urethral
Cleared on May 8, 2019 as substantially equivalent to K000070 (Rusch Intl., 2000) after a 145-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- May 8, 2019
- Review
- 145 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000070 (2000). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000070 FlocathRusch Intl. · 2000 · Recalled
- This deviceK183461 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG…Teleflexmedical, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK200134 Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK261418 Liquick X-treme, Liquick X-treme PlusTeleflex Medical · 2026
- Descendant · 2 generations on · 0 of its ownK260394 Hydrophilic coated intermittent nalaton catheter for single…Hangzhou Jimushi Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251274 EZ-Protect Hydrophilic Closed System Intermittent Catheter…HR Healthcare · 2026
- Descendant · 2 generations on · 0 of its ownK243175 Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020 · cites it directly3descendants
- K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical · 2026 · cites it directly0descendants
- K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd. · 2026 · 2 generations on0descendants
- K251274EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…HR Healthcare · 2026 · cites it directly0descendants
- K243175Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000070 | Flocath | Rusch Intl. | 2000 | 2 |
| 0 (this device) | 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 | — |
| +1 | K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | 2026 | — |
| +2 | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use… | Hangzhou Jimushi Meditech Co., Ltd. | 2026 | — |
| +1 | K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect… | HR Healthcare | 2026 | — |
| +2 | K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K000070 | FlocathSummary page 4…ification Panel: Gastroenterology/Urology E. Predicate Device This submission demonstrates substantial equivalence to the predicate device: Rusch® FloCath – K000070 F. Device Description The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Ki… | 2000 |
What descends from it? (6)
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?
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183461
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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