FDA applicant

Venous Health Systems, Inc.

Portola Valley, CA3 decisions2011–20130 recalls

FDA records 3 decisions for Venous Health Systems, Inc. (Portola Valley, CA) from 2011 to 2013: 3 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 8 predicates, 2 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 Venous Health Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011high 1 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Venous Health Systems, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Venous Health 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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Venous Health 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?