FDA applicant

Zywie, Inc.

Johns Creek, GA2 decisions2015–20260 recalls

FDA records 2 decisions for Zywie, Inc. (Johns Creek, GA) from 2015 to 2026: 2 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MWJ (Electrocardiograph, Ambulatory (Without…). Its devices cite 3 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Zywie, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Zywie, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?