PFA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Non-Invasive Central Venous Manometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1140
- Medical specialty
- Cardiovascular
- FDA definition
- Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
- Adverse events (MAUDE)
- 2024: 28 · 2025: 38 · 2026: 51
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 |
|---|---|---|
| Central Venous Pressure System (K151776) | Mespere Lifesciences, Inc. | 2015-08-12 |
| CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 (K131085) | Mespere Lifesciences, Inc. | 2013-08-22 |
Track PFA automatically
Every clearance here is in the API, with alerts when new ones post.