Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle

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

510(k) Number

K001293 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vial Connector 13mm Closed Collar

  Class II

  FDA 510(k) K132040 Active Cleared 31 Jul 2013

• MIX2VIAL Transfer Device

  Class II

  FDA 510(k) K031861 Active Cleared 29 Jul 2003

• Vial Adapter 15mm

  Class II

  FDA 510(k) K171796 Active Cleared 12 Oct 2017

• Vial2Bag Direct Connect

  Class II

  FDA 510(k) K170095 Active Cleared 8 Mar 2017

• Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle

  Class II

  FDA 510(k) K963583 Active Cleared 7 Oct 1996

• Mixject with Spray Head

  Class II

  FDA 510(k) K122023 Active Cleared 4 Oct 2012

See all devices from Medimop Medical Projects, Ltd. →

• What clinical environments is this device designed for and how is it intended to be used?

  This device is specifically designed for single-use in clinical settings like hospitals. It is intended to simplify the process of mixing and dispensing intravenous fluids from a vial by combining a dispensing pin, a detachable vial holder, and a pre-attached needle. The design ensures sterility and ease of use during fluid transfer.

• Is this device reusable or meant for single-use, and what storage requirements does it have?

  The device is explicitly intended for single-use only in clinical settings. No special storage conditions are required beyond standard medical device protocols, meaning it can be stored under typical hospital conditions without additional precautions.

• Does this device include any pre-attached components, and if so, what are they?

  Yes, this device includes a pre-attached needle along with a dispensing pin and a detachable vial holder. These components work together to streamline the transfer of intravenous fluids from a vial while maintaining sterility.

• What regulatory pathway was followed for this device, and what does that mean for its use?

  This device underwent an FDA 510(k) clearance process (K001293) and was determined to be substantially equivalent to a predicate device. The clearance was granted under a special review by the General Hospital Orthopaedic (HO) Advisory Committee, confirming its compliance with FDA standards for intravenous fluid transfer systems. This means it meets regulatory requirements for safety and effectiveness in its intended clinical use.