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FreedomEdge Syringe Infusion System

by Repro-Medical System, Inc., Dba Koru Medical Systems

510(k) K211206

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211206 Date9 Nov 2021ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
FreedomEdge(R) Syringe Infusion System
510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 FreedomEdge Syringe Infusion System is a compact, portable, mechanical infusion pump designed for delivering medications without the need for batteries or electricity. It is classified as a Class II device under FDA regulation number 880.5725 and is substantially equivalent to a predicate device, as determined by FDA 510(k) clearance K211206.

The system is intended for use in general hospital settings and is supplied as a reusable device. It includes the FreedomEdge Syringe Driver and Precision Flow Rate Tubing, and is indicated for the intravenous infusion of specific antibiotics when used as part of the system. The device is manufactured by Repro-Medical System, Inc., doing business as Koru Medical Systems, and is registered under FDA product code FRN.

Other devices from Repro-Medical System, Inc., Dba Koru Medical Systems

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the FreedomEdge Syringe Infusion System used for?

    The FreedomEdge Syringe Infusion System is indicated for the intravenous infusion of specific antibiotics when used as part of the system, and is intended for use in general hospital settings to deliver medications without relying on batteries or electricity.

  • Is the FreedomEdge Syringe Infusion System reusable or single-use?

    The system is supplied as a reusable device, meaning the FreedomEdge Syringe Driver and Precision Flow Rate Tubing are designed for multiple uses after appropriate cleaning and reprocessing, in accordance with the manufacturer’s instructions.

  • What components are included with the FreedomEdge Syringe Infusion System?

    The system includes the FreedomEdge Syringe Driver and Precision Flow Rate Tubing, which work together to provide mechanical infusion of medications without the need for batteries or electrical power.

  • How does the FreedomEdge Syringe Infusion System operate without electricity?

    The FreedomEdge Syringe Infusion System is a compact, portable mechanical infusion pump that uses mechanical energy—such as spring-driven or manual actuation—to deliver medications, eliminating the need for batteries or external electrical power sources.

  • What regulatory pathway was used for the FreedomEdge Syringe Infusion System?

    The FreedomEdge Syringe Infusion System received FDA 510(k) clearance under submission number K211206, demonstrating substantial equivalence to a predicate device, and is classified as a Class II device under FDA regulation number 880.5725.