510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213955Substantially Equivalent

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

Becton Dickinson & Co, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213955 is the FDA 510(k) clearance record for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub, a class II device, cleared for Becton, Dickinson and Company on under FDA product code QTI (Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device). FDA's definition for product code QTI reads: "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". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show no recalls naming K213955.

Clearance record

Decision date
Received
(211 days to decision)
Product code
QTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Becton, Dickinson and Company 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTI

Trailing 12 months

FDA records hold no clearances under product code QTI in the trailing twelve months.

FDA records show no clearances under product code QTI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260