> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Catheter Separation Devices are Class 2
- URL: https://www.fdaweb.com/catheter-separation-devices-are-class-2/
- Published: 2024-08-16T12:00:00.000Z
- Updated: 2026-09-14T14:38:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157591

*Federal Register* notice: FDA is classifying intravenous catheter force-activated separation devices into Class 2 (special controls). The action is based on Lineus Medical’s request for a De Novo classification of its SafeBreak Vascular, a device placed in line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failures requiring IV catheter replacement. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-16/pdf/2024-18267.pdf?ref=fdaweb.com).