# K052952: Cathassist

- Pathway: 510(k) (Traditional)
- Applicant: Physician Technologies, Inc.
- Decided: May 14, 2006 after 206 days
- Product code: KNY (Accessories, Catheter, G-U)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CathAssist™ Female Urinary Catheter Insertion Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include: 1. Major surgery; 2. Urinary retention; 3. Collection of a sterile "cath" urine specimen; 4. Bladder irrigation; and 5. Labor and Delivery. The CathAssist™ Female Urinary Catheter Insertion Accessory is intended for use by: 1. Nurses and caregivers in the rapid and easy insertion of a female urinary catheter; 2. By adult females who are required to perform intermittent self catheterization following surgery; and 3. By adult females required to self-catheterize and who have motor or visual disabilities.

Source page: https://510kreport.com/device/K052952
Methodology: https://510kreport.com/methodology