# K013345: Incare Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Jan 7, 2002 after 90 days
- Product code: KOD (Catheter, Urological)
- 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 K000070 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000070: Flocath, Rusch Intl. (2000) Summary page 1.
- (no number) Conveen Intermittent Catheters: named in the summary without a submission number
- (no number) Mentor Self Cath: named in the summary without a submission number

## Most influential descendants
- K112137: Comfortglide Intermitent Catheter (2011), 0 descendants of its own

## Indications for use
The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

Source page: https://510kreport.com/device/K013345
Methodology: https://510kreport.com/methodology