# K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Jan 14, 2002 after 87 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 K973120 (1998). 4 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003784: Mentor Self-Cath Plus, Mentor Corp. (2001) Summary page 1.
- K973120: Readycath Catheter, Medical Technologies of Georgia (1998) Summary page 1.
- K010420: Rusch MMG/O'neil Catheter, Rusch, Inc. (2001) Summary page 1.
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 1.

## Most influential descendants
- K090960: Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (2009), 15 descendants of its own
- K110862: Vapro Plus Intermittent Catheter (2011), 14 descendants of its own
- K141642: Vapro Intermittent Catheter (2014), 13 descendants of its own
- K180824: VaPro 2 Intermittent Catheter (2018), 6 descendants of its own
- K220667: Sleeved IC (2022), 3 descendants of its own

## Indications for use
The InCare Pre-lubricated 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/K013483
Methodology: https://510kreport.com/methodology