# K802665: Touchless Clean-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Diamed Division Ill. Tool Works, Inc.
- Decided: Nov 12, 1980 after 15 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3117-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Jan 11, 2021 · Class II · Z-1431-2021: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

Source page: https://510kreport.com/device/K802665
Methodology: https://510kreport.com/methodology