# K213955: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 16, 2022 after 211 days
- Product code: QTI (Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K030467 (2003). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe, Becton, Dickinson and Company (2017) Summary page 5.
- K112791: Sitescrub Ipa Device, C. R. Bard (2012) Summary page 5.

## Indications for use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled 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.

Source page: https://510kreport.com/device/K213955
Methodology: https://510kreport.com/methodology