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SafeBreak Vascular

by Lineus Medical 2 variants

510(k) K223486

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223486 Date19 May 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QOI
Device Class
Class II
Regulation
21 CFR Part 880.5220
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SafeBreak Vascular is an Intravenous Catheter Force-Activated Separation Device, designed to facilitate controlled separation of IV tubing from a catheter during use. It is engineered to prevent accidental disconnections, thereby reducing the risk of fluid leakage or contamination at the catheter hub.

This device is intended for single-use in hospital settings, including general medical care, and is supplied sterile. It is compatible with various vascular access lines such as peripheral IV catheters, midlines, peripherally inserted central catheters, central venous catheters, IV ports, and interosseous vascular access devices for patients aged two weeks and older. The device has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II medical device.

Other devices from Lineus Medical, LLC

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of vascular access lines is the SafeBreak® Vascular compatible with, and what age group can it be used on?

    The SafeBreak® Vascular is designed for use with a variety of vascular access lines, including peripheral IV catheters, midlines, peripherally inserted central catheters (PICCs), central venous catheters, IV ports, and interosseous vascular access devices. It is intended for patients aged two weeks and older, making it suitable for a broad range of hospital settings and patient populations.

  • Is the SafeBreak® Vascular meant for single-use or repeated use, and how is it supplied?

    The SafeBreak® Vascular is explicitly designed for single-use only in hospital settings. It is supplied sterile, ensuring readiness for immediate clinical application without additional preparation.

  • How does the SafeBreak® Vascular differ from standard IV tubing connections, and what safety benefit does it provide?

    Unlike traditional IV tubing connections, the SafeBreak® Vascular incorporates a force-activated separation mechanism that enables controlled disconnection of the tubing from the catheter hub. This design reduces the risk of accidental disconnections, which can lead to fluid leakage or contamination at the catheter hub—a common concern in intravenous therapy.

  • What regulatory pathway was followed for FDA clearance of the SafeBreak® Vascular, and what classification does it hold?

    The SafeBreak® Vascular received FDA clearance under the Traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device, reflecting its role in mitigating risks associated with IV disconnections in clinical settings.