FDA Product Code QOI: Intravenous Catheter Force-activated Separation Device.
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.
Leading manufacturers include Linear Health Sciences, LLC, Lineus Medical and Site Saver, Inc. D/B/A Lineus Medical.
8
Total
7
Cleared
188d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 6 in the prior period
FDA 510(k) Cleared Intravenous Catheter Force-activated Separation Device. Devices (Product Code QOI)
8 devices
Cleared
Sep 06, 2024
Orchid Safety Release Valve™
Linear Health Sciences, LLC
General Hospital
112d
Cleared
Oct 03, 2023
Orchid Safety Release ValveTM
Linear Health Sciences, LLC
General Hospital
82d
Cleared
Sep 29, 2023
SafeBreak® Vascular
Lineus Medical
General Hospital
88d
Cleared
May 19, 2023
SafeBreak® Vascular
Lineus Medical
General Hospital
179d
Cleared
May 04, 2023
Orchid Safety Release Valve
Linear Health Sciences, LLC
General Hospital
93d
Cleared
Oct 16, 2022
SafeBreak Vascular
Lineus Medical, LLC
General Hospital
31d
Cleared
May 03, 2022
Orchid Safety Release Valve(TM)
Linear Health Sciences, LLC
General Hospital
305d
Not Cleared
May 27, 2021
SafeBreak Vascular
Site Saver, Inc. D/B/A Lineus Medical
General Hospital
617d
About Product Code QOI - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QOI since 2021, with 7 receiving FDA clearance (average review time: 188 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 6 in the prior period.