FDA applicant

NuMED, Inc.

Hopkinton, NY50 decisions1985–20222 recalls

FDA records 50 decisions for NuMED, Inc. (Hopkinton, NY) from 1985 to 2022: 48 510(k) clearances, 1 De Novo grant and 1 original PMA approval. Most are in product codes DQY (Catheter, Percutaneous) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 70 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 30 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, cardiovascular panel, where it files most

How often FDA has decided NuMED, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 4 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like NuMED, 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 “NuMED”

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

Numed Technologies, Inc. 5

NuMED, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “NuMED”