# K062240: Carevent

- Pathway: 510(k) (Traditional)
- Applicant: Chief Medical, LLC
- Decided: Oct 16, 2006 after 75 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
Longest line of descent: 5 generations back to K760093 (1976). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041983: Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016, Opticon Medical (2004) Summary page 1.
- K051059: Amsure 100% Silicone Foley Catheter, Amsino International, Inc. (2005) Summary page 1.

## Indications for use
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.

Source page: https://510kreport.com/device/K062240
Methodology: https://510kreport.com/methodology