# K033208: Ivy Devices Inc. IV/Medical Line Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Devices, Inc.
- Decided: Mar 18, 2004 after 168 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.

Source page: https://510kreport.com/device/K033208
Methodology: https://510kreport.com/methodology