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Profoject Disposable Syringe with Needle

by CMT Health PTE., Ltd. Singapore 510(k)

510(k) K252033

Product code FMF

Overview

The Profoject Disposable Syringe with Needle is a single‑use, sterile, manual syringe consisting of a polypropylene barrel, a polypropylene plunger, and a polyisoprene rubber stopper. It is classified as a Class 2 medical device (product code FMF) and is identified as a syringe, piston type under the FDA nomenclature.

The device is supplied sterile and intended for single‑use applications. It is cleared under FDA 510(k) (K252033) as substantially equivalent, with a traditional clearance type. Materials are polypropylene and polyisoprene rubber, and the device is intended for general hospital use.

Summary written by AI from registry data, 27 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252033 Date25 Jul 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

Full name
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from CMT Health PTE., Ltd.

Questions

  • What is the Profoject Disposable Syringe with Needle used for?

    The Profoject Disposable Syringe with Needle is a single-use, sterile manual syringe intended for general hospital applications. It consists of a polypropylene barrel, a polypropylene plunger, and a polyisoprene rubber stopper, designed for one-time use only.

  • Is the Profoject syringe sterile and can it be reused?

    Yes, the Profoject Disposable Syringe is supplied sterile and is specifically designed for single-use applications. It should not be reused as it is intended for one-time use only to ensure patient safety and prevent cross-contamination.

  • What materials are used in the Profoject Disposable Syringe?

    The Profoject Disposable Syringe is constructed from polypropylene for both the barrel and plunger, with a polyisoprene rubber stopper. These materials are selected for their compatibility with medical applications and patient safety.

  • What is the regulatory status of the Profoject Disposable Syringe?

    The Profoject Disposable Syringe is classified as a Class 2 medical device (product code FMF) and has received FDA 510(k) clearance (K252033) as substantially equivalent under traditional clearance type for general hospital use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K252033 24 fields · synced 22 Oct 2026