510(k) · Cleared
Recalled · Class I · 2023Curity & Kenguard Silicone Coated Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendal Co. · KOD Catheter, Urological
Cleared on Mar 11, 1986 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 11, 1986
- Review
- 29 days
- Class
- Class II
- Product code
- KOD
- Recalls
- 1 (1 Class I)
- Predicates
- 0
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860484 | Curity & Kenguard Silicone Coated Foley Catheter | The Kendal Co. | 1986 | — |
| +1 | K090262 | Percucath Urinary Catheter | Percuvision, LLC | 2009 | — |
| +1 | K110214 | Directvision Catheter, Uncoated | Percuvision | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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.
1 device in this family has a Class I recall. 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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2023 | Class I | Z-1052-2024 | Nonconforming Material/Component | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090262 (Percuvision, LLC, 2009) has gone furthest, with 1 descendant 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/K860484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K860484: Curity & Kenguard Silicone Coated Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860484
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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