Pump & Detector

FDA 510(k) K813455 · Medlog GmbH Marketing Services

Substantially Equivalent

510(k) numberK813455

Submission

Device name
Pump & Detector
Applicant
Medlog GmbH Marketing Services
Mchenry, IL, US
Received
November 30, 1981
Decision date
January 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
K832086Use 77 Ultrasonic NebulizerCAF · Traditional 07/19/1983SE
K831325NutromatGBB · Traditional 06/02/1983SE
K830913Minitrop Aerosal, Prodomo Aerosal andBTT · Traditional 05/25/1983SE
K810155Dop 84 · Traditional 05/01/1981SE

Questions and answers

When was Pump & Detector cleared by the FDA?

Pump & Detector (K813455) received a 510(k) decision of Substantially Equivalent on January 5, 1982, 36 days after the submission was received.

What is the product code of K813455?

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