Mastersite Needleless Luer Activated IV Connector, Model MS 1000

by Creative Plastic Technology

510(k) K001106

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) K001106↗

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 · Traditional	NumberK001106	Date16 Aug 2000Cleared	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Withdrawn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: K001106
FDA Product Code: FPA

Device Class: Class II
Regulation: 21 CFR Part 880.5440
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 Mastersite Needleless Luer Activated IV Connector, Model MS 1000 is a needleless intravenous connector designed for secure, contamination-free fluid administration. It incorporates a luer-activated mechanism to prevent retrograde flow, ensuring a closed-system interface that reduces the risk of microbial contamination during use. This device is classified as a needleless connector under medical nomenclature authorities, facilitating safe IV access without the need for traditional needle insertion. Its design supports compatibility with standard IV tubing and administration sets, enhancing clinical workflow efficiency.

This connector is supplied as a single-use medical device, intended for use in general hospital settings where intravenous therapy is administered. It requires no additional sterilization beyond its pre-packaged, sterile condition and is compatible with standard saline flush protocols. The device adheres to FDA 510(k) clearance (K001106) under the General Hospital advisory committee category, ensuring regulatory compliance for hospital-based intravenous applications. Storage instructions specify protection from contamination and extreme temperatures, maintaining integrity until immediate clinical use.