Cleared Traditional

K213955 - 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213955 · Becton, Dickinson and Company · General Hospital
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Jul 2022
Decision
211d
Days
Class 2
Risk

K213955 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub. Classified as Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device (product code QTI), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 16, 2022 after a review of 211 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K213955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2021
Decision Date July 16, 2022
Days to Decision 211 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 128d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.