T3 Platform Software
FDA 510(k) K213230 · Etiometry, Inc.
510(k) numberK213230
Submission
- Device name
- T3 Platform Software
- Applicant
- Etiometry, Inc.
Boston, MA, US - Received
- September 29, 2021
- Decision date
- June 22, 2022
- 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 |
| 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 |
| 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 |
|---|---|---|
| K254066 | Etiometry PlatformPPW · Special | 04/03/2026SE |
| 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 |
| 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 T3 Platform Software cleared by the FDA?
T3 Platform Software (K213230) received a 510(k) decision of Substantially Equivalent on June 22, 2022, 266 days after the submission was received.
What is the product code of K213230?
The FDA product code is PPW – Adjunctive Cardiovascular Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.