# K183335: Medline Poly-Cath Red Polymer Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 12, 2019 after 191 days
- Product code: GBM (Catheter, Urethral)
- 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: 2 generations back to K810216 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040897: Dover Rob-Nel Catheter, Tyco Healthcare (2004) Summary page 4.

## Indications for use
Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male and female adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.

Source page: https://510kreport.com/device/K183335
Methodology: https://510kreport.com/methodology