FDA applicant

Osprey Medical, Inc.

Minnetonka, MN15 decisions2013–20190 recalls

FDA records 15 decisions for Osprey Medical, Inc. (Minnetonka, MN) from 2013 to 2019: 15 510(k) clearances. All are in product code DXT (Injector And Syringe, Angiographic). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 172 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 23 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Osprey Medical”.

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 Osprey Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013high 4 (2015) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Osprey Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osprey Medical, 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

Osprey Medical, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?