FDA applicant

Arstasis, Inc.

Redwood City, CA14 decisions2010–20151 recall

FDA records 14 decisions for Arstasis, Inc. (Redwood City, CA) from 2010 to 2015: 14 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DRE (Dilator, Vessel, For Percutaneous…). Its devices cite 22 predicates, 14 of them its own earlier devices. 1 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 Arstasis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010high 3 (2010) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Arstasis, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arstasis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Arstasis, 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?

What has been recalled?