510(k) Report

FDA applicant

Repro-Med Systems, Inc. Dba Rms Medical Products

New York, NY3 decisions2013–20192 recalls

FDA records 3 decisions for Repro-Med Systems, Inc. Dba Rms Medical Products (New York, NY) from 2013 to 2019: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are 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-Med Systems, Inc. Dba Rms Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013: 12017: 12019: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2019

2016: 12019: 1
2013high 1 (2016) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Repro-Med Systems, Inc. Dba Rms Medical Products by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • FRNPump, Infusion1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 20172cite it

What has FDA decided for it lately?

  • K180843HIgH-Flo Super26 Subcutaneous Needle SetsRepro-Med Systems, Inc. Dba Rms Medical Products · 2019
  • K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017
  • K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414…Repro-Med Systems, Inc. Dba Rms Medical Products · 20132 recalls

All 3 as Repro-Med Systems, Inc. Dba Rms Medical Products →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K12240420" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 -…Aug 20, 2019Class II
  • K122404HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part…Mar 10, 2016Class II

Other applicant names beginning “Repro-Med”

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

Repro-Med Systems, Inc. 7Repro-Medical System, Inc., Dba Koru Medical Systems 2Repro-Med Systems, Inc. Dba Koru Medical Systems 1