Cleared Traditional

K231161 - 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (FDA 510(k) Clearance)

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

K231161 · Becton, Dickinson and Company · General Hospital
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Jul 2023
Decision
88d
Days
Class 2
Risk

K231161 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush 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 July 21, 2023 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K231161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2023
Decision Date July 21, 2023
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K231161.
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
TK Pre-Filled Normal Saline Flush Syringe
K230756 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
Pre-filled Syringe with Saline
K220060 · Jiangsu Caina Medical Co.,Ltd · Jun 2022
AMSafe Pre-Filled Normal Saline Flush Syringe
K213522 · Amsino International, Inc. · Mar 2022