Cleared Traditional

K252204 - prolaio eVO2peak Module (Version 1.0) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K252204 · Prolaio, Inc. · Cardiovascular device
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Dec 2025
Decision
155d
Days
Class 2
Risk

K252204 is an FDA 510(k) clearance for the prolaio eVO2peak Module (Version 1.0). Classified as Adjunctive Cardiovascular Status Indicator (product code PPW), Class II - Special Controls.

Submitted by Prolaio, Inc. (Chicago, US). The FDA issued a Cleared decision on December 16, 2025 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Prolaio, Inc. devices

Submission Details

510(k) Number K252204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2025
Decision Date December 16, 2025
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PPW Adjunctive Cardiovascular Status Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2200
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05678530 Recruiting Observational Industry-sponsored

Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

1000
Patients (est.)
16
Sites
Condition studied Cardiopulmonary
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Greg Kurio, MD
Sponsor Prolaio (industry)
Started 2019-06-06 → Primary completion 2027-03-31
Primary outcome
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
View full study on ClinicalTrials.gov

Regulatory Peers - PPW Adjunctive Cardiovascular Status Indicator

All 7
Devices cleared under the same product code (PPW) and FDA review panel - the closest regulatory comparables to K252204.
Etiometry Platform
K254066 · Etiometry, Inc. · Apr 2026
Etiometry Platform (DAV 5.4 RAE 9.2)
K241479 · Etiometry, Inc. · Feb 2025
T3 Platform software
K223578 · Etiometry, Inc. · Jul 2023
T3 Platform Software
K213230 · Etiometry, Inc. · Jun 2022
CipherOx CRI Tablet
K213255 · Flashback Technologies, Inc. · Jun 2022