# K223486: SafeBreak® Vascular

- Pathway: 510(k) (Traditional)
- Applicant: Lineus Medical
- Decided: May 19, 2023 after 179 days
- Product code: QOI (Intravenous Catheter Force-Activated Separation Device.)
- Device class: 2
- Regulation: 21 CFR 880.5220
- 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 DEN190043 (2021). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222791: SafeBreak Vascular, Lineus Medical, LLC (2022) Summary page 4.

## Most influential descendants
- K231957: SafeBreak® Vascular (2023), 0 descendants of its own

## Indications for use
SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and pediatric populations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.

Source page: https://510kreport.com/device/K223486
Methodology: https://510kreport.com/methodology