FDA applicant

Agile Devices, Inc.

Wellesley, MA1 decision2022–20220 recalls

FDA records 1 decision for Agile Devices, Inc. (Wellesley, MA) in 2022: 1 510(k) clearance. All are in product code KRA (Catheter, Continuous Flush). Its devices cite 2 predicates, 0 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 Agile Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Agile Devices, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Agile Devices, 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

Other applicant names beginning “Agile”

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

Agile Distributors, LLC 1

Agile Devices, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Agile”