Cardiovascular · 510(k) · 2025
prolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.. Cleared by FDA on 16 December 2025 under submission K252204, product code PPW (adjunctive cardiovascular status indicator). What FDA's record says, in FDA's words.
Device record · K252204
- Device. prolaio eVO2peak Module (Version 1.0)DEVICE
- Company. Prolaio, Inc.COMPANY
- Decision. 16 December 2025, 510(k), substantially equivalent (traditional review); received 14 July 2025DECISION
- Panel. CardiovascularPANEL
- Product code. PPW, Adjunctive Cardiovascular Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PPW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PPW, in Cardiovascular, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.