FDA product code PFA: Non-Invasive Central Venous Manometer
PFA is the FDA product code for non-invasive central venous manometer. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under PFA. The average 510(k) review took 84 days (median 84).
Definition
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
Classification
| Field | Value |
|---|---|
| Device name | Non-Invasive Central Venous Manometer |
| Device class | Class II |
| Regulation | 21 CFR 870.1140 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PFA clearance
Top PFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mespere Lifesciences, Inc. | 2 | 2015-08-12 |
Most recent PFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151776 | Mespere Lifesciences, Inc. | Central Venous Pressure System | 2015-08-12 | 42 |
| K131085 | Mespere Lifesciences, Inc. | CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 | 2013-08-22 | 126 |
Recalls for PFA devices
openFDA lists no recalls for product code PFA.
Frequently asked questions
What is FDA product code PFA?
PFA is the FDA product code for non-invasive central venous manometer. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel.
What device class is PFA?
Class II, regulation 21 CFR 870.1140. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFA?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most PFA clearances?
Mespere Lifesciences, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PFA
- Run a recall and safety report across every PFA manufacturer
- Watch product code PFA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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