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FDA 510(k)

SDF Pro

K-Number: K250222 · 2025-05-07

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2025-05-07
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SDF Pro is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K250222. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDF Pro?

SDF Pro is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K250222.

When did SDF Pro receive FDA 510(k) clearance?

SDF Pro received FDA 510(k) clearance on 2025-05-07, under 510(k) number K250222.

Who is the listed applicant for SDF Pro?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDF Pro?

The FDA product code for SDF Pro is PHR.

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Related Devices (Code: PHR)

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.

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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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