ANNE One
FDA 510(k) clearance K223711 · decided 2023-08-10
Clearance details
- K-number
- K223711
- Device name
- ANNE One
- Applicant
- Sibel Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-12
- Decision date
- 2023-08-10
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Niles, IL, 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 |
|---|---|---|
| UbiqVue™ 2AYe Cardiac System (UX2253) (K261569) | Lifesignals, Inc. | 2026-07-09 |
| Perin Health System (PHD80060-2) (K252984) | Perin Health Devices, LLC | 2026-01-22 |
| EasyTeleMed (2.0.2) (K252440) | Ingeniars S.R.L. | 2025-10-02 |
| TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) | The ScottCare Corporation | 2025-06-04 |
| iBSM (K243837) | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| UbiqVue™ 2A Multi-parameter System (UX2550) (K242018) | Lifesignals, Inc. | 2024-11-12 |
| BioButton System (K241101) | Biointellisense, Inc. | 2024-09-26 |
| ANNE Chest (K240251) | Sibel Health, Inc. | 2024-06-03 |
| HD+12, HD+15 (K220526) | Cardioline S.P.A | 2023-05-15 |
| Alio (K223073) | Alio, Inc. | 2023-03-17 |
| Care Team Portal (K222398) | Vivify Health, Inc. | 2023-02-06 |
| BioButton System (K212957) | Biolntellisense, Inc. | 2022-12-12 |
Recalls involving this device
No recalls on record reference this clearance.