FDA applicant

Repro-Med Systems, Inc.

Middletown, NY7 decisions1984–20111 recall

FDA records 7 decisions for Repro-Med Systems, Inc. (Middletown, NY) from 1984 to 2011: 6 510(k) clearances and 1 original PMA approval. Most are in product codes BSY (Catheters, Suction, Tracheobronchial) and FRN (Pump, Infusion). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 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-Med Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Repro-Med Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Repro-Med Systems, Inc.’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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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. Dba Rms Medical Products 3 Repro-Medical System, Inc., Dba Koru Medical Systems 2 Repro-Med Systems, Inc. Dba Koru Medical Systems 1

Repro-Med Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Repro-Med”