Spectrum-2
FDA 510(k) clearance K254129 · decided 2026-05-22
Clearance details
- K-number
- K254129
- Device name
- Spectrum-2
- Applicant
- Neko Health AB
- Decision
- Substantially Equivalent
- Date received
- 2025-12-22
- Decision date
- 2026-05-22
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- MUD
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danderyd, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Masimo O3 Regional Oximeter (K243324) | Masimo Corporation | 2025-07-17 |
| Lap.Ox™ Laparoscopic Tissue Oximeter (K250519) | ViOptix, Inc. | 2025-06-26 |
| Cerebral Autoregulation Index (CAI) Algorithm (K240596) | Edwards Lifesciences | 2024-10-16 |
| ODI-Tech (K241393) | Odi Medical AS | 2024-08-30 |
| SnapshotNIR model KD205 (K240601) | Kent Imaging, Inc. | 2024-04-02 |
| OxiplexTS200 (K232385) | Iss Medical, Inc. | 2024-03-01 |
| Intra.Ox™ 2.0 Handheld Tissue Oximeter (K233488) | Vioptix, Inc. | 2024-02-28 |
| Edwards Algorithm for Measurement of Blood Hemoglobin (K230612) | Edwards Lifesciences, LLC | 2023-11-17 |
| Cerebral Adaptive Index (CAI) Algorithm (K223651) | Edwards Lifesciences, LLC | 2023-05-26 |
| Masimo O3 Regional Oximeter System (K214072) | Masimo Corporation | 2022-05-06 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K221010) | Vioptix, Inc. | 2022-05-03 |
| INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) | Covidien, LLC | 2021-12-05 |
Recalls involving this device
No recalls on record reference this clearance.