SmartSpectra Vital Signs Monitor 1.0
FDA 510(k) clearance K254169 · decided 2026-06-18
Clearance details
- K-number
- K254169
- Device name
- SmartSpectra Vital Signs Monitor 1.0
- Applicant
- Presage Security, Inc. d/b/a Presage Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-23
- Decision date
- 2026-06-18
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- QME
- Device class
- 2
- Regulation number
- 870.2785
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Leesburg, VA, US
- 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 |
|---|---|---|
| Anura Mobile Core SDK (M1) (K253650) | Nuralogix Corporation | 2026-06-11 |
| PanopticAI Vital Signs (1.6.1-22) (K260066) | PanopticAI Technologies Limited | 2026-05-21 |
| Vital Signs (K251200) | Oxehealth Limited | 2026-02-02 |
| Vital Signs (K243687) | Oxehealth Limited | 2025-08-27 |
| Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (K250078) | Mindset Medical, Inc. | 2025-05-30 |
| PanopticAI Vital Signs (K240890) | PanopticAI technologies Limited | 2024-12-23 |
| Informed Vital Core Application (IVC App) (K241633) | Mindset Medical, Inc. | 2024-11-18 |
| FibriCheck (K232804) | Qompium NV | 2024-06-07 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK) (K223622) | Faceheart Corp. | 2023-09-01 |
| Oxehealth Vital Signs (K220899) | Oxehealth Limited | 2022-04-29 |
| Vital Signs (K211906) | Oxehealth Limited | 2021-07-20 |
| Oxehealth Vital Signs (DEN200019) | Oxehealth Limited | 2021-03-26 |
Recalls involving this device
No recalls on record reference this clearance.