510(k) Report

FDA applicant

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

New York, NY2 decisions2021–20220 recalls

FDA records 2 decisions for Repro-Medical System, Inc., Dba Koru Medical Systems (New York, NY) from 2021 to 2022: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Repro-Medical System, Inc., Dba Koru Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Repro-Medical System, Inc., Dba Koru Medical Systems by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Repro-Medical System, Inc., Dba Koru…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRNPump, Infusion2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211206FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 20211cites it
  • K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 20221cites it

What has FDA decided for it lately?

  • K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2022
  • K211206FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2021

All 2 as Repro-Medical System, Inc., Dba Koru Medical Systems →

Other applicant names beginning “Repro-Medical”

FDA records each applicant name separately; these may or may not be the same firm.

Repro-Med Systems, Inc. 7Repro-Med Systems, Inc. Dba Rms Medical Products 3Repro-Med Systems, Inc. Dba Koru Medical Systems 1