PPW
- Product code
- PPW
- Device name
- Adjunctive Cardiovascular Status Indicator
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2200
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254066 | 2026-04-03 | Etiometry, Inc. | Etiometry Platform | |
| K252204 | 2025-12-16 | Prolaio, Inc. | prolaio eVO2peak Module (Version 1.0) | |
| K241479 | 2025-02-12 | Etiometry, Inc. | Etiometry Platform (DAV 5.4 RAE 9.2) | FDA |
Official FDA classification page: PPW
Classification and pathway per current FDA publications. Data from openFDA (CC0).