510(k) · Cleared
ClearedOrchid Safety Release Valve™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linear Health Sciences, LLC · QOI Intravenous Catheter Force-Activated Separation Device.
Cleared on Sep 6, 2024 as substantially equivalent to K232094 (Linear Health Sciences, LLC, 2023) after a 112-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Sep 6, 2024
- Review
- 112 days
- Class
- Class II
- Product code
- QOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN190043 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN190043 SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical · 2021
- 3 generations backK212064 Orchid Safety Release Valve (TM)Linear Health Sciences, LLC · 2022
- 2 generations backK230266 Orchid Safety Release ValveLinear Health Sciences, LLC · 2023
- 1 generation backK232094 Orchid Safety Release ValveTMLinear Health Sciences, LLC · 2023
- This deviceK241415 Orchid Safety Release Valve™Linear Health Sciences, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | 2021 | — |
| −3 | K212064 | Orchid Safety Release Valve (TM) | Linear Health Sciences, LLC | 2022 | — |
| −2 | K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023 | — |
| −1 | K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023 | — |
| 0 (this device) | K241415 | Orchid Safety Release Valve™ | Linear Health Sciences, LLC | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QOI device
- #1 K232094 Orchid Safety Release ValveTMscore 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232094 | Orchid Safety Release ValveTMSummary page 6…Device Name: Orchid Safety Release ValveTM Page 1 of 6 510(k) Number: K232094 Product Classification: Class II Regulation Number: 21 CFR § 880.5220 V. Device Description… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QOI devicesQOI Intravenous Catheter Force-Activated Separation Device.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QOI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QOI
91in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOI
No recall names QOI since 2007.
Adverse event reports per year · QOI
64in 2025
MAUDE reports naming product code QOI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 4 | 91 | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (126 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241415: Orchid Safety Release Valve™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241415
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026