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FDA 510(k)

mdprostate

K-Number: K252571 · 2026-08-07

ApplicantMediaire GmbH
Decision Date2026-08-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

mdprostate is the device name listed in this FDA 510(k) record. The listed applicant is Mediaire GmbH. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K252571. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mdprostate?

mdprostate is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Mediaire GmbH. The 510(k) number is K252571.

When did mdprostate receive FDA 510(k) clearance?

mdprostate received FDA 510(k) clearance on 2026-08-07, under 510(k) number K252571.

Who is the listed applicant for mdprostate?

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

What is the FDA product code for mdprostate?

The FDA product code for mdprostate is QIH.

Related Devices (Code: QIH)

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.

K253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.K261349SwiftMRAirs Medical, Inc.K260192DIANAROPCA ApS

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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