FDA 510(k)

Virtus

K-Number: K261366 · 2026-06-12

Decision Date2026-06-12

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Virtus is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261366. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virtus?

Virtus is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Somnomed, Inc.. The 510(k) number is K261366.

When did Virtus receive FDA 510(k) clearance?

Virtus received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261366.

Who is the listed applicant for Virtus?

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

What is the FDA product code for Virtus?

The FDA product code for Virtus is LRK.

Other records listing Somnomed, 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.

K233497Rest Assure System K183443SomnoDent Avant K162306SomnoDent ALPHA

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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.