QOI
8 FDA 510(k) clearances · Product code
112 daysmedian time to decision
617 days90th percentile
8clearances measured
FDA profile
- Official device name
- Intravenous Catheter Force-Activated Separation Device.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5220
- Medical specialty
- General Hospital
- 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.
- Adverse events (MAUDE)
- 2025: 64
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Orchid Safety Release Valve™ (K241415) | Linear Health Sciences, LLC | 2024-09-06 |
| Orchid Safety Release ValveTM (K232094) | Linear Health Sciences, LLC | 2023-10-03 |
| SafeBreak® Vascular (K231957) | Lineus Medical | 2023-09-29 |
| SafeBreak® Vascular (K223486) | Lineus Medical | 2023-05-19 |
| Orchid Safety Release Valve (K230266) | Linear Health Sciences, LLC | 2023-05-04 |
| SafeBreak Vascular (K222791) | Lineus Medical, LLC | 2022-10-16 |
| Orchid Safety Release Valve(TM) (K212064) | Linear Health Sciences, LLC | 2022-05-03 |
| SafeBreak Vascular (DEN190043) | Site Saver, Inc. D/B/A Lineus Medical | 2021-05-27 |
Track QOI automatically
Every clearance here is in the API, with alerts when new ones post.