T3 Software
FDA 510(k) K151715 · Etiometry, Inc.
510(k) numberK151715
Submission
- Device name
- T3 Software
- Applicant
- Etiometry, Inc.
Boston, MA, US - Received
- June 25, 2015
- Decision date
- October 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, 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 |
| 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 |
| K142732 | T3 SoftwareMWI · Traditional | 03/04/2015SE |
Questions and answers
When was T3 Software cleared by the FDA?
T3 Software (K151715) received a 510(k) decision of Substantially Equivalent on October 29, 2015, 126 days after the submission was received.
What is the product code of K151715?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.