# K860484: Curity & Kenguard Silicone Coated Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: The Kendal Co.
- Decided: Mar 11, 1986 after 29 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090262: Percucath Urinary Catheter (2009), 1 descendant of its own
- K110214: Directvision Catheter, Uncoated (2011), 0 descendants of its own

## Recalls of this device
- Dec 4, 2023 · Class I · Z-1052-2024: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Source page: https://510kreport.com/device/K860484
Methodology: https://510kreport.com/methodology