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FDA 510(k)

XTRA4

K-Number: K251320 · 2025-09-11

Decision Date2025-09-11
Product CodeLYX
DecisionSubstantially Equivalent

Device Summary

XTRA4 is the device name listed in this FDA 510(k) record. The listed applicant is Al.Chi.Mi.A. S.R.L. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251320. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTRA4?

XTRA4 is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Al.Chi.Mi.A. S.R.L. The 510(k) number is K251320.

When did XTRA4 receive FDA 510(k) clearance?

XTRA4 received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251320.

Who is the listed applicant for XTRA4?

The FDA 510(k) record lists Al.Chi.Mi.A. S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRA4?

The FDA product code for XTRA4 is LYX.

Other records listing Al.Chi.Mi.A. S.R.L 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.

Related Devices (Code: LYX)

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.

Official Source

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