# K231957: SafeBreak® Vascular

- Pathway: 510(k) (Traditional)
- Applicant: Lineus Medical
- Decided: Sep 29, 2023 after 88 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: 3 generations back to DEN190043 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223486: SafeBreak® Vascular, Lineus Medical (2023) Summary page 5.

## Indications for use
SafeBreak® Vascular is intended to separate when excessive tension is exerted across intravenous (IV) and intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV or IO catheter. SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters, midlines, peripherally inserted central catheter (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs in adults and pediatric populations two (2) weeks of age and older receiving intermittent or continuous infusions with an electronic pump.

Source page: https://510kreport.com/device/K231957
Methodology: https://510kreport.com/methodology