Submission Details
| 510(k) Number | K252204 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
prolaio eVO2peak Module (Version 1.0)
Dec 2025
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K252204 is an FDA 510(k) clearance for the prolaio eVO2peak Module (Version 1.0), a Adjunctive Cardiovascular Status Indicator (Class II — Special Controls, product code PPW), submitted by Prolaio, Inc. (Chicago, US). The FDA issued a Cleared decision on December 16, 2025, 155 days after receiving the submission on July 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2200.
Device Classification
| Product Code | PPW — Adjunctive Cardiovascular Status Indicator |
| Device Class | Class II — 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. |
Manufacturer
Similar Devices — PPW Adjunctive Cardiovascular Status Indicator
K241479 · Etiometry, Inc.
· Feb 2025
K223578 · Etiometry, Inc.
· Jul 2023
K213230 · Etiometry, Inc.
· Jun 2022
K213255 · Flashback Technologies, Inc.
· Jun 2022
K173929 · Flashback Technologies, Inc.
· Jul 2018
DEN160020 · Flashback Technologies, Inc.
· Dec 2016