Data / Medical devices / United States / Koru Medical Systems, Inc.
Koru Medical Systems, Inc.: FDA-registered device maker in Mahwah, NJ, United States, 9 510(k) clearances
Koru Medical Systems, Inc. is registered with the FDA (registration 3024122953) in Mahwah, NJ, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024122953
- Address
- 100 Corporate Drive, Mahwah, NJ, United States, 07430
- Owner or operator
- KORU Medical Systems, Inc. (1318360)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 20, 2007
- Registered through
- 2026
- Brand names listed
- Freedom Infusion System, FreedomEdge Infusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoglobulin G (Igg) Infusion System | PKP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | FRN | Substantially Equivalent | Koru Medical Systems, Inc. | accessdata.fda.gov |
| November 3, 2023 | K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | FRN | Substantially Equivalent | Koru Medical Systems | accessdata.fda.gov |
| April 29, 2022 | K214045 | FreedomEdge Syringe Infusion System | FRN | Substantially Equivalent | Repro-Medical System, Inc., Dba Koru Medical Systems | accessdata.fda.gov |
| December 15, 2021 | K200176 | FREEDOM Integrated Syringe Infusion System | FRN | Substantially Equivalent | Repro-Med Systems, Inc. Dba Koru Medical Systems | accessdata.fda.gov |
| November 9, 2021 | K211206 | FreedomEdge(R) Syringe Infusion System | FRN | Substantially Equivalent | Repro-Medical System, Inc., Dba Koru Medical Systems | accessdata.fda.gov |
| August 31, 2017 | K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | FRN | Substantially Equivalent | Repro-Med Systems, Inc. Dba Rms Medical Products | accessdata.fda.gov |
| May 6, 2013 | K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 | FPA | Substantially Equivalent | Repro-Med Systems, Inc. Dba Rms Medical Products | accessdata.fda.gov |
| May 20, 2011 | K102512 | RMS SUBCUTANEOUS NEEDLE SET | FPA | Substantially Equivalent | Repro-Med Systems, Inc. | accessdata.fda.gov |
| May 18, 1994 | K933652 | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING | FRN | Substantially Equivalent - Subject to Tracking Reg. | Repro-Med Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Immunoglobulin G (Igg) Infusion System
- All makers of Pump, Infusion
Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.