prolaio eVO2peak Module (Version 1.0)
FDA 510(k) K252204 · Prolaio, Inc.
510(k) numberK252204
Submission
- Device name
- prolaio eVO2peak Module (Version 1.0)
- Applicant
- Prolaio, Inc.
Chicago, IL, US - Received
- July 14, 2025
- Decision date
- December 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPW – Adjunctive Cardiovascular Status Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2200
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code PPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254066 | Etiometry PlatformPPW · Special | Etiometry, Inc. | 04/03/2026SE |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2)PPW · Traditional | Etiometry, Inc. | 02/12/2025SE |
| K223578 | T3 Platform softwarePPW · Traditional | Etiometry, Inc. | 07/07/2023SE |
| K213230 | T3 Platform SoftwarePPW · Traditional | Etiometry, Inc. | 06/22/2022SE |
| K213255 | CipherOx CRI TabletPPW · Traditional | Flashback Technologies, Inc. | 06/17/2022SE |
| K173929 | CipherOx CRI M1PPW · Traditional | Flashback Technologies, Inc. | 07/24/2018SE |
Questions and answers
When was prolaio eVO2peak Module (Version 1.0) cleared by the FDA?
prolaio eVO2peak Module (Version 1.0) (K252204) received a 510(k) decision of Substantially Equivalent on December 16, 2025, 155 days after the submission was received.
What is the product code of K252204?
The FDA product code is PPW – Adjunctive Cardiovascular Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.