Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5220](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5220) → QOI — Intravenous Catheter Force-Activated Separation Device.

# QOI · Intravenous Catheter Force-Activated Separation Device.

_General Hospital · 21 CFR 880.5220 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI

## Overview

- **Product Code:** QOI
- **Device Name:** Intravenous Catheter Force-Activated Separation Device.
- **Regulation:** [21 CFR 880.5220](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5220)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) 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.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In combination with the general controls of the FD&C Act, intravenous catheter force-activated separation device is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241415](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K241415.md) | Orchid Safety Release Valve™ | Linear Health Sciences, LLC | Sep 6, 2024 | SESE |
| [K232094](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K232094.md) | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | Oct 3, 2023 | SESE |
| [K231957](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K231957.md) | SafeBreak® Vascular | Lineus Medical | Sep 29, 2023 | SESE |
| [K223486](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K223486.md) | SafeBreak® Vascular | Lineus Medical | May 19, 2023 | SESE |
| [K230266](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K230266.md) | Orchid Safety Release Valve | Linear Health Sciences, LLC | May 4, 2023 | SESE |
| [K222791](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K222791.md) | SafeBreak Vascular | Lineus Medical, LLC | Oct 16, 2022 | SESE |
| [K212064](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/K212064.md) | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | May 3, 2022 | SESE |
| [DEN190043](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI/DEN190043.md) | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | May 27, 2021 | DENG |

## Top Applicants

- Linear Health Sciences, LLC — 4 clearances
- Lineus Medical — 2 clearances
- Lineus Medical, LLC — 1 clearance
- Site Saver, Inc. D/B/A Lineus Medical — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOI)

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