FDA applicant

Barosense, Inc.

Redwood City, CA5 decisions2009–20120 recalls

FDA records 5 decisions for Barosense, Inc. (Redwood City, CA) from 2009 to 2012: 5 510(k) clearances. Most are in product codes OCW (Endoscopic Tissue Approximation Device) and FED (Endoscopic Access Overtube…). Its devices cite 9 predicates, 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2012

2009high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Barosense, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Barosense, 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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Barosense, Inc.

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?