Cleared Special

0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH (K141311) - FDA 510(k) Clearance

Also marketed or referenced as:
SP SYRINGE, SF SYRINGE

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141311 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
66d
Days
Class 2
Risk

K141311 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH. 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 July 25, 2014 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K141311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2014
Decision Date July 25, 2014
Days to Decision 66 days
Submission Type Special
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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 19
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K141311.
0.9% Sodium Chloride Injection, USP
K173348 · Medline Industries, Inc. · Jun 2018
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
K161552 · Becton, Dickinson and Company · Feb 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
K153481 · Becton, Dickinson and Company · Apr 2016
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
K121050 · Becton, Dickinson & CO · Feb 2013