# K032710: Closed System Intermittent Catheterization Kit

- Pathway: 510(k) (Traditional)
- Applicant: Apogee Medical, Inc.
- Decided: Jan 9, 2004 after 129 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: 2 generations back to K973120 (1998). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 1.
- K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit, Hollister, Inc. (2002) Summary page 1.

## Most influential descendants
- K160877: United Urologics Closed System Catheter (2016), 0 descendants of its own
- K080878: MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit) (2008), 0 descendants of its own

## Indications for use
The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.

Source page: https://510kreport.com/device/K032710
Methodology: https://510kreport.com/methodology