Intravenous Catheter Force-activated Separation Device.
General Hospital · 21 CFR 880.5220
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 MDR events
73 adverse event reports on file
- MCKESSON BRANDSMar 12, 2026InjuryHarsoria Healthcare1451040-2026-00018
- MCKESSON BRANDSMar 9, 2026MalfunctionHarsoria Healthcare1451040-2026-00016
- MCKESSON BRANDSMar 9, 2026MalfunctionHarsoria Healthcare1451040-2026-00017
- MCKESSON BRANDSFeb 13, 2026InjuryHarsoria Healthcare1451040-2026-00011
- MVKESSON BRANDSFeb 4, 2026MalfunctionHarsoria Healthcare1451040-2026-00007
- MCKESSON BRANDSJan 7, 2026MalfunctionShinchang Medical Co., Ltd1451040-2026-00002
- MCKESSON BRANDSDec 10, 2025MalfunctionHarsoria Healthcare1451040-2025-00120
- MCKESSON BRANDSDec 9, 2025MalfunctionHarsoria Healthcare1451040-2025-00118
- MCKESSON BRANDSDec 4, 2025MalfunctionHarsoria Healthcare1451040-2025-00116
- MCKESSON BRANDSDec 4, 2025MalfunctionHarsoria Healthcare1451040-2025-00117
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
18 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Linear Health Sciences, LLCSep 6, 2024
K241415 · Orchid Safety Release Valve
- Linear Health Sciences, LLCOct 3, 2023
K232094 · Orchid Safety Release ValveTM
- Lineus MedicalSep 29, 2023
K231957 · SafeBreak® Vascular
- Lineus MedicalMay 19, 2023
K223486 · SafeBreak® Vascular
- Linear Health Sciences, LLCMay 4, 2023
K230266 · Orchid Safety Release Valve
- Lineus Medical, LLCOct 16, 2022
K222791 · SafeBreak Vascular
- Linear Health Sciences, LLCMay 3, 2022
K212064 · Orchid Safety Release Valve(TM)
- Site Saver, Inc. D/B/A Lineus MedicalMay 27, 2021
DEN190043 · SafeBreak Vascular