Spectrum-2— 510(k) K254129
Substantially EquivalentNeko Health AB
FDA 510(k) clearance K254129 for Spectrum-2, Substantially Equivalent on 2026-05-22. Applicant: Neko Health AB. Device class: 2.
Summary
Neko Health's Spectrum-2 is filed under MUD, tissue saturation oximeters. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 870.2700. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Neko Health filed from Danderyd, Sweden. The decision came 151 calendar days after receipt (December 22, 2025 to May 22, 2026).
Clearance details
- Applicant
- Neko Health AB
- Product code
- Product code MUD
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danderyd, SE
Recent devices under product code MUD
view allMore clearances from Neko Health AB
view allAdverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.