FDA applicant

Ensite Vascular

Olathe, KS2 decisions2019–20210 recalls

FDA records 2 decisions for Ensite Vascular (Olathe, KS) from 2019 to 2021: 2 510(k) clearances. All are in product code DXC (Clamp, Vascular). 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 Ensite Vascular’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Ensite Vascular by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ensite Vascular’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

Other applicant names beginning “Ensite”

FDA records each applicant name separately; these may or may not be the same firm.

Ensite Vacular, LLC 1

Ensite Vascular

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ensite”