Automed 3300 and 3400 Infusion Pump System

FDA 510(k) K023491 · Help Technologies

Substantially Equivalent

510(k) numberK023491

Submission

Device name
Automed 3300 and 3400 Infusion Pump System
Applicant
Help Technologies
Dana Point, CA, US
Received
October 17, 2002
Decision date
December 13, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRN – Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

Other 510(k)s with product code FRN

510(k)DeviceApplicantDecision
K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional Deka R&D Corp07/24/2026SE
K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional Koru Medical Systems, Inc.01/28/2026SE
K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional Baxter Healthcare Corporation07/28/2025SE
K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional Baxter Healthcare Corporation07/28/2025SE
K242752MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional Iradimed Corporation05/28/2025SE
K243855BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional Carefusion 303, Inc.04/25/2025SE
K242115Plum Duo™ Precision IV PumpFRN · Traditional Icu Medical, Inc.04/02/2025SE
K242114Plum Solo™ Precision IV PumpFRN · Traditional Icu Medical, Inc.04/02/2025SE
K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionFRN · Special Deka Research & Development Corp.03/11/2025SE
K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional Deka Research and Development Corp.01/16/2025SE

More from Deka Research and Development Corp.

510(k)DeviceDecision
K023973Automed 3200 Infusion PumpFRN · Traditional 02/27/2003SE
K023863Automed 3000 Infusion PumpFRN · Traditional 02/07/2003SE
K003915Accufuser; Accufuser PlusMEB · Traditional 02/15/2001SE

Questions and answers

When was Automed 3300 and 3400 Infusion Pump System cleared by the FDA?

Automed 3300 and 3400 Infusion Pump System (K023491) received a 510(k) decision of Substantially Equivalent on December 13, 2002, 57 days after the submission was received.

What is the product code of K023491?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.