510(k) · Cleared
ClearedAll Silicone Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Medical Corp. · KOD Catheter, Urological
Cleared on Feb 12, 1990 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Feb 12, 1990
- Review
- 117 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- Descendant · cites it directly · 19 of its ownK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- Descendant · 2 generations on · 10 of its ownK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
- Descendant · 2 generations on · 6 of its ownK130908 Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK013276 All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002
- Descendant · 3 generations on · 1 of its ownK233094 Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K981612All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…Rochester Medical Corp. · 1998 · cites it directly19descendants
- K082815Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008 · 2 generations on10descendants
- K130908Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013 · 2 generations on6descendants
- K013276All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002 · 2 generations on2descendants
- K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| +1 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| +2 | K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | 2008 | — |
| +2 | K130908 | Disposable Silicone Foley Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 2013 | — |
| +2 | K013276 | All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) | Sewoon Medical Co., Ltd. | 2002 | — |
| +3 | K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 212 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?
- Of its descendants, K981612 (Rochester Medical Corp., 1998) has gone furthest, with 19 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/K896053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896053: All Silicone Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896053
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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