QOI — Intravenous Catheter Force-Activated Separation Device. Class II
Classification Details
- Product Code
- QOI
- Device Class
- Class II
- Regulation Number
- 880.5220
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241415 | linear health sciences | Orchid Safety Release Valve | September 6, 2024 |
| K232094 | linear health sciences | Orchid Safety Release ValveTM | October 3, 2023 |
| K231957 | lineus medical | SafeBreak® Vascular | September 29, 2023 |
| K223486 | lineus medical | SafeBreak® Vascular | May 19, 2023 |
| K230266 | linear health sciences | Orchid Safety Release Valve | May 4, 2023 |
| K222791 | lineus medical | SafeBreak Vascular | October 16, 2022 |
| K212064 | linear health sciences | Orchid Safety Release Valve(TM) | May 3, 2022 |
| DEN190043 | site saver, inc. d/b/a lineus medical | SafeBreak Vascular | May 27, 2021 |