510(k) · Cleared
Recalled · Class II · 2019Flocath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · KOD Catheter, Urological
Cleared on Feb 18, 2000 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 18, 2000
- Review
- 39 days
- Class
- Class II
- Product code
- KOD
- Recalls
- 2
- Predicates
- 0
21 later devices descend from it, 6 citing it directly.
- This deviceK000070 FlocathRusch Intl. · 2000
- Descendant · cites it directly · 6 of its ownK183461 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG…Teleflexmedical, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK062444 HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters…Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007
- Descendant · cites it directly · 4 of its ownK161344 GentleCath Glide Intermittent CatheterConvatec Limited · 2016
- Descendant · 2 generations on · 3 of its ownK200134 Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK181206 GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…Teleflexmedical, Inc. · 2019 · cites it directly6descendants
- K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007 · cites it directly5descendants
- K161344GentleCath Glide Intermittent CatheterConvatec Limited · 2016 · cites it directly4descendants
- K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020 · 2 generations on3descendants
- K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000070 | Flocath | Rusch Intl. | 2000 | — |
| +1 | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic… | Teleflexmedical, Inc. | 2019 | — |
| +1 | K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | 2007 | — |
| +1 | K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016 | — |
| +2 | K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020 | — |
| +1 | K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent… | 2019 | 6 |
| K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | 2007 | 5 |
| K161344 | GentleCath Glide Intermittent Catheter | 2016 | 4 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | 2018 | 3 |
| K013345 | Incare Intermittent Catheter | 2002 | 1 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2019 | Class II | Z-2086-2019 | Equipment maintenance | Potential for product not to be sterile. |
| May 21, 2014 | Class II | Z-1732-2014 | Mixed-up of materials/components | Product was packaged with a straight catheter rather than the correct coude (curved) catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183461 (Teleflexmedical, Inc., 2019) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 0 | — | 0 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K000070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000070: Flocath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000070
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026