# DEN190043: SafeBreak Vascular

- Pathway: De Novo (Direct)
- Applicant: Site Saver, Inc. D/B/A Lineus Medical
- Decided: May 27, 2021 after 617 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K212064: Orchid Safety Release Valve (TM) (2022), 3 descendants of its own
- K230266: Orchid Safety Release Valve (2023), 2 descendants of its own
- K222791: SafeBreak Vascular (2022), 2 descendants of its own
- K232094: Orchid Safety Release ValveTM (2023), 1 descendant of its own
- K223486: SafeBreak® Vascular (2023), 1 descendant 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/DEN190043
Methodology: https://510kreport.com/methodology