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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

by Excelsior Medical Corporation

510(k) K142620

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142620 Date12 Dec 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2948-2018 FDA Class II initiated 1 Feb 2018

    Packaged with an incorrect overwrap.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NGT
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a sterile, isotonic Saline, Vascular Access Flush (OpenFDA classification) designed for intravenous administration. It provides a physiologically compatible solution of 0.9% sodium chloride in water for injection, intended to maintain vascular access patency, flush catheters, or serve as a diluent for compatible parenteral medications.

Supplied as single-use, prefilled syringes in volumes of 2.5 mL (3 mL syringe), 3 mL (10 mL syringe), 5 mL (10 mL syringe), and 10 mL (10 mL syringe), the solution is non-pyrogenic and sterile-filtered. It is classified as a Class II device under FDA regulations (21 CFR 880.5200) and holds a FDA 510(k) clearance (K142620) for general hospital use. Storage requires protection from light and contamination, adhering to standard parenteral product handling protocols.

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