# K110214: Directvision Catheter, Uncoated

- Pathway: 510(k) (Special)
- Applicant: Percuvision
- Decided: May 27, 2011 after 122 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: 2 generations back to K860484 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090262: Percucath Urinary Catheter, Percuvision, LLC (2009) Summary page 1.
- K860484: Curity & Kenguard Silicone Coated Foley Catheter, The Kendal Co. (1986) Summary page 1.

## Indications for use
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine.

Source page: https://510kreport.com/device/K110214
Methodology: https://510kreport.com/methodology