510(k) · Cleared
ClearedOrchid Safety Release Valve (TM)
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 May 3, 2022 as substantially equivalent to DEN190043 (Site Saver, Inc. D/B/A Lineus Medical, 2021) after a 305-day review. Its family tree reaches back 1 generation to 2021. 3 later devices descend from it.
- Decided
- May 3, 2022
- Review
- 305 days
- Class
- Class II
- Product code
- QOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190043 (2021). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN190043 SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical · 2021
- This deviceK212064 Orchid Safety Release Valve (TM)Linear Health Sciences, LLC · 2022
- Descendant · cites it directly · 2 of its ownK230266 Orchid Safety Release ValveLinear Health Sciences, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK232094 Orchid Safety Release ValveTMLinear Health Sciences, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK241415 Orchid Safety Release Valve™Linear Health Sciences, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K230266Orchid Safety Release ValveLinear Health Sciences, LLC · 2023 · cites it directly2descendants
- K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC · 2023 · 2 generations on1descendant
- K241415Orchid Safety Release Valve™Linear Health Sciences, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | 2021 | — |
| 0 (this device) | K212064 | Orchid Safety Release Valve (TM) | Linear Health Sciences, LLC | 2022 | — |
| +1 | K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023 | — |
| +2 | K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023 | — |
| +3 | K241415 | Orchid Safety Release Valve™ | Linear Health Sciences, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | DEN190043 | SafeBreak VascularSummary page 5…Page 5 === Manufacturer: Site Saver, Inc. d/b/s Lineus Medical Device Name: SafeBreak® Vascular 510(k) Number: DEN190043 Product Classification: Class II Regulation Number: 21 CFR §880.5220 V. Device Description The… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230266 | Orchid Safety Release Valve | 2023 | 2 |
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?
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. 2022, 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 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…
Read the full statement (127 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212064: Orchid Safety Release Valve (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212064
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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