510(k) Report

FDA applicant

Polarean, Inc.

Research Triangle Park, NC4 decisions2022–20240 recalls

FDA records 4 decisions for Polarean, Inc. (Research Triangle Park, NC) from 2022 to 2024: 4 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 69 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2022: 22023: 12024: 1
2022high 2 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Polarean, 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?

  • MOSCoil, Magnetic Resonance, Specialty3decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 56 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 69 days; 3 of its 4 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.

  • K212239XENOVIEW 3.0T Chest CoilPolarean, Inc. · 20221cites it
  • K231647XENOVIEW 3.0T Chest CoilPolarean, Inc. · 20231cites it

What has FDA decided for it lately?

  • K243316XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2024
  • K231647XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2023
  • K223071Xenoview VDPPolarean, Inc. · 2022
  • K212239XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2022

All 4 as Polarean, Inc. →