FDA product code · General hospital

Intravenous Catheter Force-Activated Separation Device.

Name: FDA decisions, review times, recalls and adverse event reports for product code QOI
Creator: 510(k) Report

QOIClass II21 CFR 880.5220510(k) required8 decisions since 20210 recalls

8 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 93 days (half between 85 and 146). No recall names this code. The most-cited predicate is DEN190043, named by 2 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of QOI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QOI

1in 2024

2007high 4 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QOI

91in 2023

2007high 91 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QOI

No recall names QOI since 2007.

Adverse event reports per year · QOI

64in 2025

2007high 64 (2025) · low 0 (2007)2025

MAUDE reports naming product code QOI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	2	—	1
2023	4	91	1
2024	1	—	1
2025	0	—	64
2026	0	—	—

FIG. 1 — QOI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QOI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Intravenous Catheter Force-Activated Separation Device.

Which predicates do QOI devices cite most?

Which QOI devices have the deepest lineage?

What has FDA decided in QOI lately?