Etiometry Platform
FDA 510(k) K254066 · Etiometry, Inc.
510(k) numberK254066
Submission
- Device name
- Etiometry Platform
- Applicant
- Etiometry, Inc.
Dedham, MA, US - Received
- December 18, 2025
- Decision date
- April 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K252204 | prolaio eVO2peak Module (Version 1.0)PPW · Traditional | Prolaio, Inc. | 12/16/2025SE |
| 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 |
More from Flashback Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2)PPW · Traditional | 02/12/2025SE |
| K223578 | T3 Platform softwarePPW · Traditional | 07/07/2023SE |
| K213423 | T3 Platform softwarePLB · Traditional | 01/06/2023SE |
| K213230 | T3 Platform SoftwarePPW · Traditional | 06/22/2022SE |
| K202306 | T3 Platform softwareMWI · Traditional | 11/25/2020SE |
| K190273 | T3 Platform softwareMWI · Traditional | 12/08/2019SE |
| K163065 | T3 SoftwareMWI · Traditional | 05/26/2017SE |
| K152258 | T3 SoftwarePLB · Traditional | 03/31/2016SE |
| K151715 | T3 SoftwareMWI · Traditional | 10/29/2015SE |
| K142732 | T3 SoftwareMWI · Traditional | 03/04/2015SE |
Questions and answers
When was Etiometry Platform cleared by the FDA?
Etiometry Platform (K254066) received a 510(k) decision of Substantially Equivalent on April 3, 2026, 106 days after the submission was received.
What is the product code of K254066?
The FDA product code is PPW – Adjunctive Cardiovascular Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.