Merit 20 mL Syringe

by Merit Medical Systems, Inc.

510(k) K152783

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K152783↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK152783	Date7 Dec 2015Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K152783
FDA product code: FMF

Device class: Class II
Regulation: 21 CFR Part 880.5860
Advisory committee: General Hospital
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Merit 20 mL Syringe is a Plastic Syringe (Device Type: FMF) designed for precise fluid administration, aspiration, or transfer in clinical settings. Constructed with a 20 mL capacity, it features a luer lock connection for secure attachment to needles or tubing. Its design supports dynamic applications, including high-pressure procedures involving saline or contrast media. The device is intended for general hospital use, adhering to standards for sterile, single-use medical instruments.

This syringe is supplied sterile, intended for single-use only, and is regulated under FDA 510(k) clearance (K152783) as substantially equivalent to a predicate device. It is manufactured by Merit Medical Systems, Inc., and distributed in sizes and configurations tailored for coronary control applications, though the 20 mL variant is broadly applicable. Storage requires protection from contamination and extreme temperatures. No MRI safety classification is specified, and compliance with domestic and international regulatory standards is implied through internal quality systems.

From the manufacturer

Since 1987 Merit Medical has been manufacturing and selling a variety of coronary control syringes. With years of experience, Merit has designed and created quality control syringes with features that continue to meet ever changing clinical expectations.

Source: merit.com