De Novo · Granted
GrantedSafeBreak Vascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Site Saver, Inc. D/B/A Lineus Medical · QOI Intravenous Catheter Force-Activated Separation Device.
Granted on May 27, 2021 as a new device type through De Novo after a 617-day review. 7 later devices descend from it.
- Decided
- May 27, 2021
- Review
- 617 days
- Class
- Class II
- Product code
- QOI
- Recalls
- None
7 later devices descend from it, 2 citing it directly.
- This deviceDEN190043 SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical · 2021
- Descendant · cites it directly · 3 of its ownK212064 Orchid Safety Release Valve (TM)Linear Health Sciences, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK230266 Orchid Safety Release ValveLinear Health Sciences, LLC · 2023
- Descendant · cites it directly · 2 of its ownK222791 SafeBreak VascularLineus Medical, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK232094 Orchid Safety Release ValveTMLinear Health Sciences, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK223486 SafeBreak® VascularLineus Medical · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212064Orchid Safety Release Valve (TM)Linear Health Sciences, LLC · 2022 · cites it directly3descendants
- K230266Orchid Safety Release ValveLinear Health Sciences, LLC · 2023 · 2 generations on2descendants
- K222791SafeBreak VascularLineus Medical, LLC · 2022 · cites it directly2descendants
- K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC · 2023 · 3 generations on1descendant
- K223486SafeBreak® VascularLineus Medical · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | 2021 | — |
| +1 | K212064 | Orchid Safety Release Valve (TM) | Linear Health Sciences, LLC | 2022 | — |
| +2 | K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023 | — |
| +1 | K222791 | SafeBreak Vascular | Lineus Medical, LLC | 2022 | — |
| +3 | K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023 | — |
| +2 | K223486 | SafeBreak® Vascular | Lineus Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K212064 (Linear Health Sciences, LLC, 2022) has gone furthest, with 3 descendants of its own.
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. 2021, 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?
SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter.
SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190043 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190043: SafeBreak Vascular.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190043
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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