FDA 510(k)

Spectrum-2

K-Number: K254129 · 2026-05-22

Decision Date2026-05-22

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Spectrum-2 is the device name listed in this FDA 510(k) record. The listed applicant is Neko Health AB. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K254129. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum-2?

Spectrum-2 is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Neko Health AB. The 510(k) number is K254129.

When did Spectrum-2 receive FDA 510(k) clearance?

Spectrum-2 received FDA 510(k) clearance on 2026-05-22, under 510(k) number K254129.

Who is the listed applicant for Spectrum-2?

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

What is the FDA product code for Spectrum-2?

The FDA product code for Spectrum-2 is MUD.

Other records listing Neko Health AB 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.

K253911Derma-2

Related Devices (Code: MUD)

K243324Masimo O3 Regional OximeterMasimo Corporation K250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences K241393ODI-TechOdi Medical AS K240601SnapshotNIR model KD205Kent Imaging, Inc.K232385OxiplexTS200Iss Medical, 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.