QOIClass II

Intravenous Catheter Force-Activated Separation Device.

21 CFR 880.5220 / General Hospital

QOI is the FDA product code for Intravenous Catheter Force-Activated Separation Device., a class II device type, regulated under 21 CFR 880.5220. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2024-09-06, and no recalls.

Classification record

Product code: QOI
Device name: Intravenous Catheter Force-Activated Separation Device.
FDA 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.
Regulation: 21 CFR 880.5220
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 0

Clearances, product code QOI

By decision year

8 clearances under product code QOI with a decision year between 2021 and 2024, 2023 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code QOI by decision year
Year	Clearances
2021	1
2022	2
2023	4
2024	1

Applicants with the most clearances

Product code QOI

Applicants holding the most 510(k) clearances under product code QOI
Applicant	Clearances
Linear Health Sciences LLC	4
Lineus Medical	3
Site Saver, Inc. D/B/A Lineus Medical	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QOI

Recent recalls

Product code QOI

FDA records show no recalls under product code QOI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)