# K212064: Orchid Safety Release Valve (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Linear Health Sciences, LLC
- Decided: May 3, 2022 after 305 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.
3 later devices descend from it; 1 cites it directly.
0 of 5 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
- K230266: Orchid Safety Release Valve (2023), 2 descendants of its own
- K232094: Orchid Safety Release ValveTM (2023), 1 descendant of its own
- K241415: Orchid Safety Release Valve™ (2024), 0 descendants of its own

## Indications for use
The Linear Health Sciencesm Orchid Safety Release ValveTM is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRVTM is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRVTM is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRVTM separates and closes the flow path in both directions. The Orchid SRVTM can be used during intermittent and continuous infusion. The Orchid SRVTM is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. The Orchid SRVTM is for use with patients eighteen (18) years of age and older.

Source page: https://510kreport.com/device/K212064
Methodology: https://510kreport.com/methodology