# K254129: Spectrum-2

- Pathway: 510(k) (Traditional)
- Applicant: Neko Health AB
- Decided: May 22, 2026 after 151 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K963903 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181623: Clarifi Imaging System, Modulated Imaging, Inc. (2018) Summary page 6.

## Indications for use
The Spectrum-2 device is indicated for use to record and monitor changes in oxygenation levels in superficial tissues during circulatory or perfusion examinations for individuals with potential circulatory compromise.

Source page: https://510kreport.com/device/K254129
Methodology: https://510kreport.com/methodology