FDA applicant

Ni Medical

Warrington, PA3 decisions1997–20090 recalls

FDA records 3 decisions for Ni Medical (Warrington, PA) from 1997 to 2009: 3 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) and DRX (Electrode, Electrocardiograph). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “N.I. Medical, Ltd.”.

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 Ni Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Ni Medical

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?