# K182511: SimplCath

- Pathway: 510(k) (Traditional)
- Applicant: F&S Medical Solutions, LLC
- Decided: Mar 20, 2019 after 189 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 K910876 (1991). 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)
- K961361: Asta-Cath, A+ Products (1996) Summary page 4.

## Indications for use
The SimplCath™, Female Urethra Catheterization-Assisting Device, is intended for urological use only. It is designed for use by healthcare personnel for catheterization of the female bladder. The device is to be inserted into the vagina before catheterization of the urethra.

Source page: https://510kreport.com/device/K182511
Methodology: https://510kreport.com/methodology