Not Cleared Direct

DEN190043 - SafeBreak Vascular (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190043 · Site Saver, Inc. D/B/A Lineus Medical · General Hospital
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May 2021
Decision
617d
Days
Class 2
Risk

DEN190043 is an FDA 510(k) submission (not cleared) for the SafeBreak Vascular. Classified as Intravenous Catheter Force-activated Separation Device. (product code QOI), Class II - Special Controls.

Submitted by Site Saver, Inc. D/B/A Lineus Medical (Fayetteville, US). The FDA issued a Not Cleared (DENG) decision on May 27, 2021 after a review of 617 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5220 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 617 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Site Saver, Inc. D/B/A Lineus Medical devices

Submission Details

510(k) Number DEN190043 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 18, 2019
Decision Date May 27, 2021
Days to Decision 617 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
489d slower than avg
Panel avg: 128d · This submission: 617d
Pathway characteristics

Device Classification

Product Code QOI Intravenous Catheter Force-activated Separation Device.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5220
Definition An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QOI Intravenous Catheter Force-activated Separation Device.

All 7
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