510(k) · Cleared
Clearedprolaio eVO2peak Module (Version 1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prolaio, Inc. · PPW Adjunctive Cardiovascular Status Indicator
Cleared on Dec 16, 2025 as substantially equivalent to K173929 (Flashback Technologies, Inc., 2018) after a 155-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Dec 16, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- PPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160020 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PPW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PPW device
- #1 K213230 T3 Platform Softwarescore 15.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173929 | CipherOx CRI M1Summary page 5…2 Regulation Number 21 CFR§870.2200 Product Code PPW PREDICATE DEVICE Category Description Device Trade Name CipherOx CRI M1 (K173929) Common Name Adjunctive Cardiovascular Status Indicator Classification Name Adjunctive Cardiovascular Status Indi… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PPW devicesPPW Adjunctive Cardiovascular Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PPW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PPW
Too few PPW 510(k)s in any year since 2007 to give a median.
Recalls per year · PPW
No recall names PPW since 2007.
Adverse event reports per year · PPW
No MAUDE report names PPW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252204: prolaio eVO2peak Module (Version 1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252204
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026