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FDA 510(k)

XSTAT P15

K-Number: K253290 · 2025-11-12

ApplicantRevmedx, Inc.
Decision Date2025-11-12
Product CodePGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSTAT P15 is the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K253290. The device is classified under product code PGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XSTAT P15?

XSTAT P15 is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Revmedx, Inc.. The 510(k) number is K253290.

When did XSTAT P15 receive FDA 510(k) clearance?

XSTAT P15 received FDA 510(k) clearance on 2025-11-12, under 510(k) number K253290.

Who is the listed applicant for XSTAT P15?

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

What is the FDA product code for XSTAT P15?

The FDA product code for XSTAT P15 is PGZ.

Other records listing Revmedx, Inc. 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.

K210676XSTAT 30 PouchK180051XSTAT 30, 1-PackK170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackK161020XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

Related Devices (Code: PGZ)

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.

K210676XSTAT 30 PouchRevmedx, Inc.K180051XSTAT 30, 1-PackRevmedx, Inc.K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc.K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc.

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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