Cleared Special

K161552 - 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (FDA 510(k) Clearance)

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

K161552 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
241d
Days
Class 2
Risk

K161552 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush SP 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 February 2, 2017 after a review of 241 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K161552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2016
Decision Date February 02, 2017
Days to Decision 241 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 128d · This submission: 241d
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 40
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K161552.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · Becton, Dickinson and Company · Dec 2025
Praxiject™ SP 0.9% NaCl
K233623 · Medxl, Inc. · Feb 2024
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · Spm Medicare Pvt. , Ltd. · Nov 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
K231363 · Hantech Medical Device Co., Ltd. · Sep 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · Anhui Tianyang Pharmaceutical Co., Ltd. · Aug 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023