FDA product code QOI: Intravenous Catheter Force-Activated Separation Device.
QOI is the FDA product code for intravenous catheter force-activated separation device.. It is a Class II device, regulated under 21 CFR 880.5220 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under QOI, 7 in the last five years, from 3 different applicants. The average 510(k) review took 127 days (median 93); 112 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intravenous Catheter Force-Activated Separation Device. |
| Device class | Class II |
| Regulation | 21 CFR 880.5220 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QOI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 168 |
| 2023 | 4 | 110 |
| 2024 | 1 | 112 |
Compare with all 510(k) review times · Search every QOI clearance
Top QOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Linear Health Sciences, LLC | 4 | 2024-09-06 |
| Lineus Medical | 2 | 2023-09-29 |
| Lineus Medical, LLC | 1 | 2022-10-16 |
Most recent QOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241415 | Linear Health Sciences, LLC | Orchid Safety Release Valve | 2024-09-06 | 112 |
| K232094 | Linear Health Sciences, LLC | Orchid Safety Release ValveTM | 2023-10-03 | 82 |
| K231957 | Lineus Medical | SafeBreak® Vascular | 2023-09-29 | 88 |
| K223486 | Lineus Medical | SafeBreak® Vascular | 2023-05-19 | 179 |
| K230266 | Linear Health Sciences, LLC | Orchid Safety Release Valve | 2023-05-04 | 93 |
Recalls for QOI devices
openFDA lists no recalls for product code QOI.
Frequently asked questions
What is FDA product code QOI?
QOI is the FDA product code for intravenous catheter force-activated separation device.. It is a Class II device, regulated under 21 CFR 880.5220 and reviewed by the General Hospital panel.
What device class is QOI?
Class II, regulation 21 CFR 880.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code QOI?
Across 7 cleared submissions the average was 127 days from receipt to decision (median 93).
Which companies have the most QOI clearances?
Linear Health Sciences, LLC (4); Lineus Medical (2); Lineus Medical, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QOI
- Run a recall and safety report across every QOI manufacturer
- Watch product code QOI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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