Cleared Traditional

K183473 - AMSafe(R) Pre-Filled Normal Saline Flush Syringe (FDA 510(k) Clearance)

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

K183473 · Amsino International, Inc. · General Hospital
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Jul 2019
Decision
210d
Days
Class 2
Risk

K183473 is an FDA 510(k) clearance for the AMSafe(R) Pre-Filled Normal Saline Flush Syringe. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on July 12, 2019 after a review of 210 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.

View all Amsino International, Inc. devices

Submission Details

510(k) Number K183473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2018
Decision Date July 12, 2019
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 128d · This submission: 210d
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 K183473.
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
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
K231161 · Becton, Dickinson and Company · Jul 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