# K150550: SilverCoat Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: Nov 24, 2015 after 266 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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 K052168 (2006). 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)
- K052168: Medline Silvertouch 100% Silicone Foley Catheter, Model Medline Industries, Inc., Medline Industries, Inc. (2006) Summary page 5.

## Indications for use
To be used as a urological catheter inserted through the urethra to pass urine from the urinary tract by individuals that are > 30 kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

Source page: https://510kreport.com/device/K150550
Methodology: https://510kreport.com/methodology