# K252204: prolaio eVO2peak Module (Version 1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Prolaio, Inc.
- Decided: Dec 16, 2025 after 155 days
- Product code: PPW (Adjunctive Cardiovascular Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160020 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173929: CipherOx CRI M1, Flashback Technologies, Inc. (2018) Summary page 5.

## Indications for use
The prolaio eVO2peak Module (Version 1.0) is an all-software medical device intended to be used for estimating peak oxygen consumption (eVO2peak (mL/kg/min)) in adult patients for whom such VO2 Peak cardiopulmonary functional testing is desired. The prolaio eVO2peak Module uses as inputs: demographic data and single-lead electrocardiogram (sampled at least 125 Hz) and triaxial accelerometry data (sampled at 50 Hz) from qualified third-party FDA-cleared wearable medical sensors from patients carrying out activities of daily living. The prolaio eVO2peak Module is intended to provide information as an adjunctive aid in the clinical evaluation of patients by qualified clinicians who have the responsibility for interpreting its significance in connection with other standard of care clinical findings. The prolaio eVO2peak Module is not intended to be used as a diagnostic, for active patient monitoring, to be solely relied upon for determining patient status, or as an alarm device.

Source page: https://510kreport.com/device/K252204
Methodology: https://510kreport.com/methodology