FDA 510(k)

Koios DS (3.8)

K-Number: K253884 · 2026-07-02

Decision Date2026-07-02

Product CodePOK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Koios DS (3.8) is the device name listed in this FDA 510(k) record. The listed applicant is Koios Medical, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K253884. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Koios DS (3.8)?

Koios DS (3.8) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Koios Medical, Inc.. The 510(k) number is K253884.

When did Koios DS (3.8) receive FDA 510(k) clearance?

Koios DS (3.8) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K253884.

Who is the listed applicant for Koios DS (3.8)?

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

What is the FDA product code for Koios DS (3.8)?

The FDA product code for Koios DS (3.8) is POK.

Other records listing Koios Medical, 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.

K242130Koios DS K212616Koios DS K190442Koios DS for Breast

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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.