QTI · Class II · 21 CFR 880.5200

FDA Product Code QTI: Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

Prefilled Saline Flush Syringe With An Integrated Disinfection Unit Is Intended To Be Used As A Disinfection Cleaner For Needleless Access Devices Attached To Indwelling Vascular Access Devices (vads) And Flushing Of These Vads.

Leading manufacturers include Becton, Dickinson and Company.

1
Total
1
Cleared
211d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device Devices (Product Code QTI)

1 devices
1–1 of 1
Cleared Jul 16, 2022
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
K213955
Becton, Dickinson and Company
General Hospital · 211d

About Product Code QTI - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTI since 2022, with 1 receiving FDA clearance (average review time: 211 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QTI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →