# K222791: SafeBreak Vascular

- Pathway: 510(k) (Special)
- Applicant: Lineus Medical, LLC
- Decided: Oct 16, 2022 after 31 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: 1 generation back to DEN190043 (2021). 1 ancestor in all.
2 later devices descend 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)
- DEN190043: SafeBreak Vascular, Site Saver, Inc. D/B/A Lineus Medical (2021) Summary page 5.

## Most influential descendants
- K223486: SafeBreak® Vascular (2023), 1 descendant of its own
- 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 adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

Source page: https://510kreport.com/device/K222791
Methodology: https://510kreport.com/methodology