510(k) Report

FDA applicant

Nuvascular, Inc.

Irvine, CA2 decisions2025–20260 recalls

FDA records 2 decisions for Nuvascular, Inc. (Irvine, CA) from 2025 to 2026: 2 510(k) clearances. All are in product code KRD (Device, Vascular, For Promoting Embolization). Its devices cite 3 predicates, 1 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 Nuvascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Nuvascular, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nuvascular, 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

Which product codes does it file in?

  • KRDDevice, Vascular, For Promoting Embolization2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K250133HARBOR Occlusion DeviceNuvascular, Inc. · 20251cites it

What has FDA decided for it lately?

  • K260635HARBOR Occlusion DeviceNuvascular, Inc. · 2026
  • K250133HARBOR Occlusion DeviceNuvascular, Inc. · 2025

All 2 as Nuvascular, Inc. →