# K951260: Urinary Intermittent Catheters W/O Hydromer Hydrophilic Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Biosearch Medical Products, Inc.
- Decided: Sep 27, 1995 after 190 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- 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.
0 of 3 devices 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.

## Most influential descendants
- K132619: Classic Intermittent Catheter (2013), 0 descendants of its own
- K112137: Comfortglide Intermitent Catheter (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K951260
Methodology: https://510kreport.com/methodology