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FDA 510(k)

Planmed XFI

K-Number: K250318 · 2025-09-26

ApplicantPlanmed OY
Decision Date2025-09-26
Product CodeSFV
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmed XFI is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250318. The device is classified under product code SFV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Planmed XFI?

Planmed XFI is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Planmed OY. The 510(k) number is K250318.

When did Planmed XFI receive FDA 510(k) clearance?

Planmed XFI received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250318.

Who is the listed applicant for Planmed XFI?

The FDA 510(k) record lists Planmed OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Planmed XFI?

The FDA product code for Planmed XFI is SFV.

Other records listing Planmed OY as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211720Planmed Clarity 2D, Planmed Clarify SK213278Planmed VerityK192317Planmed Clarity 2D and Clarity SK180918Planmed VerityK163328Planmed Clarity

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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