KORU MEDICAL SYSTEMS, INC.

FDA Device Registration & Listing · Mahwah, NJ, US · Registration 3024122953

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024122953
FEI Number
3024122953
Entity Name
KORU MEDICAL SYSTEMS, INC.
City/State/Country
Mahwah, NJ, US
Establishment Address
100 Corporate Drive, Mahwah, NJ 07430, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
KORU Medical Systems, Inc. (Owner Number: 1318360)
Owner / Operator Contact Address
100 Corporate Dr, Mahwah, NJ 07430, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K102512
PMA Number
N/A

All Registered Proprietary Names

Freedom Infusion System Freedom Infusion System FreedomEdge Infusion System Freedom Infusion System Freedom Infusion System Freedom Infusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-08-06
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-12-16
PKP Immunoglobulin G (Igg) Infusion System General Hospital Class 2 880.5725 2021-12-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-12-16
PKP Immunoglobulin G (Igg) Infusion System General Hospital Class 2 880.5725 2026-03-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-03-16
FRN Pump, Infusion General Hospital Class 2 880.5725 2026-03-16
FRN Pump, Infusion General Hospital Class 2 880.5725 2022-09-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-09-09
PKP Immunoglobulin G (Igg) Infusion System General Hospital Class 2 880.5725 2022-09-09
PKP Immunoglobulin G (Igg) Infusion System General Hospital Class 2 880.5725 2017-09-12
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-09-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-09-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-12-14

Official Correspondent

Christine Trefethen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KORU Medical Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024122953. Last updated year: 2026. Please use registration number 3024122953 when referencing this establishment in official correspondence.
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