Cleared Traditional

K153481 - 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

K153481 is an FDA 510(k) clearance for 0.9% Sodium Chloride Injection, manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with product code NGT cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K153481 · Becton, Dickinson and Company · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
123d
Days
Class 2
Risk

K153481 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on April 4, 2016 after a review of 123 days - within the typical 510(k) review window.

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.

View all Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K153481

510(k) Number K153481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2015
Decision Date April 04, 2016
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGT Device Classification - Class 2, Special Controls

Product Code NGT Saline, Vascular Access Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
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.

Regulatory Peers - NGT Saline, Vascular Access Flush

All 39
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K153481.
0.9% Sodium Chloride Injection, USP
K173348 · Medline Industries, Inc. · Jun 2018
Praxiject 0.9% NaCl
K171109 · Medxl, Inc. · Dec 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
K161552 · Becton, Dickinson and Company · Feb 2017
Normal Saline Flush
K150143 · Nurse Assist, Inc. · Aug 2015
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
K142620 · Excelsior Medical Corporation · Dec 2014
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K133685 · Am USA · Aug 2014