Data / Medical devices / Sweden / Neko Health AB
Neko Health AB: FDA-registered device maker in Solna, Sweden, 3 510(k) clearances
Neko Health AB is registered with the FDA (registration 3042165671) in Solna, Sweden. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 22, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042165671
- Address
- Ekensbergsvagen 117, Solna, Sweden, 171 41
- Owner or operator
- Neko Health AB (10094483)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 28, 2026
- Registered through
- 2026
- Brand names listed
- Derma-2, Echo-2, Positioner-1, Spectrum-2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ballistocardiograph | DXR | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Still, Surgical | FTT | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate | QOK | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Camera, Surgical | FXR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 22, 2026 | K254240 | Echo-2 | QOK | Substantially Equivalent | Neko Health AB | accessdata.fda.gov |
| May 22, 2026 | K254129 | Spectrum-2 | MUD | Substantially Equivalent | Neko Health AB | accessdata.fda.gov |
| May 20, 2026 | K253911 | Derma-2 | LHQ | Substantially Equivalent | Neko Health AB | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Camera, Surgical
- All makers of Oximeter, Tissue Saturation
- All makers of Camera, Still, Surgical
- All makers of System, Telethermographic (Adjunctive Use)
Updated September 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.