DeviceClearance

Product code QOI— General Hospital

SafeBreak Vascular

Classification name
Intravenous Catheter Force-Activated Separation Device.
Device class
Class 2
Regulation
21 CFR 880.5220
Advisory panel
General Hospital
Total cleared
8
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QOI under 21 CFR 880.5220, via openFDA

Market context for product code QOI

FDA has cleared 8 devices under product code QOI between 2021 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QOI

Adverse events under product code QOI

product code QOI
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QOI

Data sourced from openFDA. This site is unofficial and independent of the FDA.