Devices · Prolaio, Inc.

prolaio eVO2peak Module (Version 1.0)

Prolaio, Inc. is listed for prolaio eVO2peak Module (Version 1.0) (K252204). The FDA list gives December 16, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PPW as “Adjunctive Cardiovascular Status Indicator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252204

Official FDA database record

Date of final decision

December 16, 2025

Company on the FDA list

Prolaio, Inc.

Lead panel

Cardiovascular

Primary product code

PPW

openFDA device name for the code

Adjunctive Cardiovascular Status Indicator

Device class

2

Regulation number

870.2200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary