# K230266: Orchid Safety Release Valve

- Pathway: 510(k) (Traditional)
- Applicant: Linear Health Sciences, LLC
- Decided: May 4, 2023 after 93 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.
2 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)
- K212064: Orchid Safety Release Valve (TM), Linear Health Sciences, LLC (2022) Summary page 5.

## Most influential descendants
- 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 ScienceTM 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 infusion 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 two (2) weeks of age and older.

Source page: https://510kreport.com/device/K230266
Methodology: https://510kreport.com/methodology