PPW

Adjunctive Cardiovascular Status Indicator

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-04-03.

NumberDecision dateApplicantDevice nameSummary
K2540662026-04-03Etiometry, Inc.Etiometry PlatformPDF
K2522042025-12-16Prolaio, Inc.prolaio eVO2peak Module (Version 1.0)PDF
K2414792025-02-12Etiometry, Inc.Etiometry Platform (DAV 5.4 RAE 9.2)FDA

2 summaries are archived here for direct download.

Official FDA classification page: PPW
Classification and pathway per current FDA publications. Data from openFDA (CC0).