# K172541: Medline Catheter Specimen Collector

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Feb 22, 2018 after 183 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
Longest line of descent: 1 generation back to K041464 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041464: Busse Hospital Disposables Urethral Catheter, Busse Hospital Disposables (2004) Summary page 4.

## Indications for use
Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

Source page: https://510kreport.com/device/K172541
Methodology: https://510kreport.com/methodology