PHV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2120
- Medical specialty
- Clinical Chemistry
- FDA definition
- Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
- Adverse events (MAUDE)
- 2022: 674 · 2023: 820 · 2024: 284 · 2025: 170 · 2026: 96
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE (DEN140016) | Dexcom, Inc. | 2014-08-19 |
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