FDA applicant

Baronova, Inc.

San Carlos, CA4 decisions2018–20190 recalls

FDA records 4 decisions for Baronova, Inc. (San Carlos, CA) from 2018 to 2019: 3 510(k) clearances and 1 original PMA approval. Most are in product codes FCX (Insufflator, Automatic Carbon-Dioxide For…) and QGG (Esophageal Sheath With Distal Balloon Anchor). Its devices cite 4 predicates, 1 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 Baronova, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2019

2018high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Baronova, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baronova, 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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Baronova, 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?