Cleared Traditional

K142620 - 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 (FDA 510(k) Clearance)

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

K142620 · Excelsior Medical Corporation · General Hospital
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Dec 2014
Decision
87d
Days
Class 2
Risk

K142620 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chl.... Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Excelsior Medical Corporation (Neptune, US). The FDA issued a Cleared decision on December 12, 2014 after a review of 87 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.

View all Excelsior Medical Corporation devices

Submission Details

510(k) Number K142620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2014
Decision Date December 12, 2014
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K142620.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
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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