510(k) Report

FDA applicant

Skydance Vascular, Inc.

Pleasant Grove, UT3 decisions2023–20250 recalls

FDA records 3 decisions for Skydance Vascular, Inc. (Pleasant Grove, UT) from 2023 to 2025: 3 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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, general hospital panel, where it files most

How often FDA has decided Skydance Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 22025: 1
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Skydance Vascular, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Skydance Vascular, 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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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 129 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223018OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc. · 20231cites it
  • K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. · 20231cites it

What has FDA decided for it lately?

  • K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc. · 2025
  • K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. · 2023
  • K223018OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc. · 2023

All 3 as Skydance Vascular, Inc. →