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Bioject Needle-Free Injection Management System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121270

by Bioject Medical Technologies, Inc.

Identifiers

510(k) Number
K121270 FDA 510(k)
FDA Product Code
KZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5430 FDA 510(k)
Regulation Number
880.5430 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bioject Needle-Free Injection Management System is a non-electrically powered fluid injector classified under regulation number 880.5430. It is designed for the delivery of fluids without the use of needles, as indicated by its device classification and FDA 510(k) clearance.

This device is supplied as a reusable system for use in general hospital settings. It received FDA 510(k) clearance (K121270) on July 19, 2012, following a traditional review process, and is classified as a Class II medical device with product code KZE.

Frequently asked questions

What is the Bioject Needle-Free Injection Management System used for?

It is designed for the delivery of fluids without the use of needles, as indicated by its classification under regulation number 880.5430 and intended for general hospital settings.

Is the Bioject Needle-Free Injection Management System reusable or single-use?

The device is supplied as a reusable system, meaning it can be used multiple times following appropriate cleaning and maintenance procedures in general hospital environments.

What regulatory pathway was used for the Bioject Needle-Free Injection Management System?

It received FDA 510(k) clearance through a traditional review process, with clearance granted on July 19, 2012, under K121270, and is classified as a Class II device with product code KZE.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (K121270) — FDA 510(k ..., K121270 - Bioject Needle-free Injection Management System, BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM 510 (k) K121270 - FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bioject Medical Technologies, Inc.

Sources (1)

  • FDA 510(k) K121270 24 fields · synced Sep 21, 2026