← Product Code [QOI](/productcode/QOI) · K260478

# CleanBreak™ (K260478)

_Icu Medical, Inc. · QOI · Nov 6, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260478

## Device Facts

- **Applicant:** Icu Medical, Inc.
- **Product Code:** [QOI](/productcode/QOI.md)
- **Decision Date:** Nov 6, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5220
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/device/K260478](https://fda.innolitics.com/device/K260478)

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