# K041464: Busse Hospital Disposables Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables
- Decided: Nov 5, 2004 after 156 days
- Product code: EZD (Catheter, Straight)
- 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. The FDA summary names no predicate by number.

## Most influential descendants
- K172541: Medline Catheter Specimen Collector (2018), 0 descendants of its own
- K080007: Graduated Adapter with Clave (2008), 0 descendants of its own

## Indications for use
The device is a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract.

Source page: https://510kreport.com/device/K041464
Methodology: https://510kreport.com/methodology