510(k) · Cleared
ClearedSafeBreak® Vascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lineus Medical · QOI Intravenous Catheter Force-Activated Separation Device.
Cleared on Sep 29, 2023 as substantially equivalent to K223486 (Lineus Medical, 2023) after an 88-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Sep 29, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- QOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN190043 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K223486 | SafeBreak® VascularSummary page 5…Class II Regulation Number: 21 CFR 880.5220 Panel: General Hospital Product Code: QOI Primary Predicate: K223486, SafeBreak® Vascular Manufacturer: Lineus Medical Reference Device: K230266, Orchid Safet… | 2023 |
| † | K230266 | Orchid Safety Release Valve | 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 2 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 3 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. 2023, 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 intravenous (IV) and intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV or IO catheter. SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement. SafeBreak® Vascular is intended to be used on…
Read the full statement (111 words)
SafeBreak® Vascular is intended to separate when excessive tension is exerted across intravenous (IV) and intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV or IO catheter.
SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement.
SafeBreak® Vascular is intended to be used on peripheral IV catheters, midlines, peripherally inserted central catheter (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs in adults and pediatric populations two (2) weeks 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/K231957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231957: SafeBreak® Vascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231957
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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