Cleared Traditional

K223486 - SafeBreak® Vascular (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223486 · Lineus Medical · General Hospital
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May 2023
Decision
179d
Days
Class 2
Risk

K223486 is an FDA 510(k) clearance for the SafeBreak® Vascular. Classified as Intravenous Catheter Force-activated Separation Device. (product code QOI), Class II - Special Controls.

Submitted by Lineus Medical (Fayetteville, US). The FDA issued a Cleared decision on May 19, 2023 after a review of 179 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lineus Medical devices

Submission Details

510(k) Number K223486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2022
Decision Date May 19, 2023
Days to Decision 179 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 128d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

MRC Global, LLC
Dawn Norman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 7
Devices cleared under the same product code (QOI) and FDA review panel - the closest regulatory comparables to K223486.
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