San Francisco, CA, US · 8 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 4 | 2026-05-29 |
| DSH | Recorder, Magnetic Tape, Medical | Class II | Cardiovascular | 2 | 2025-08-15 |
| DSI | — | — | — | 1 | 2024-10-30 |
| QYX | — | — | — | 1 | 2024-10-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-09-28 | Class II | Ongoing | Z-0183-2023 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambu… | — | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches l… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-29 | K252859 | ZEUS Platform (FG0501US) | DQK | Class II | Cardiovascular |
| 2025-08-15 | K243650 | Zio® monitor (DFG0001) | DSH | Class II | Cardiovascular |
| 2024-10-30 | K240177 | Zio AT® device (A100A1001) | DSI | — | — |
| 2024-10-21 | K240029 | Zio AT® device (A100A1001) | QYX | — | — |
| 2023-02-15 | K222389 | ZEUS System | DQK | Class II | Cardiovascular |
| 2022-07-19 | K213409 | ZEUS System (Zio Watch) | DQK | Class II | Cardiovascular |
| 2021-05-21 | K202527 | Zio ECG Utilization Software (ZEUS) System | DQK | Class II | Cardiovascular |
| 2021-05-21 | K202359 | Zio Monitor | DSH | Class II | Cardiovascular |