510(k) Report

FDA applicant

Obsidio, Inc.

Columbia, SC1 decision2022–20221 recall

FDA records 1 decision for Obsidio, Inc. (Columbia, SC) in 2022: 1 510(k) clearance. All are in product code KRD (Device, Vascular, For Promoting Embolization). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1, 1 Class I
2022high 1 (2024) · low 0 (2022)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KRDDevice, Vascular, For Promoting Embolization1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213385GEMObsidio, Inc. · 20221cites it

What has FDA decided for it lately?

  • K213385GEMObsidio, Inc. · 20221 Class I recall

The one decision as Obsidio, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K213385Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010Feb 20, 2024Class I