# K241415: Orchid Safety Release Valve™

- Pathway: 510(k) (Traditional)
- Applicant: Linear Health Sciences, LLC
- Decided: Sep 6, 2024 after 112 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: 4 generations back to DEN190043 (2021). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232094: Orchid Safety Release ValveTM, Linear Health Sciences, LLC (2023) Summary page 6.

## Indications for use
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion. The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement. The Orchid SRV™ is for use with patients two (2) weeks of age and older.

Source page: https://510kreport.com/device/K241415
Methodology: https://510kreport.com/methodology