Etiometry Platform
FDA 510(k) clearance K254066 · decided 2026-04-03
Clearance details
- K-number
- K254066
- Device name
- Etiometry Platform
- Applicant
- Etiometry, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-18
- Decision date
- 2026-04-03
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- PPW
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dedham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| prolaio eVO2peak Module (Version 1.0) (K252204) | Prolaio, Inc. | 2025-12-16 |
| Etiometry Platform (DAV 5.4 RAE 9.2) (K241479) | Etiometry, Inc. | 2025-02-12 |
| T3 Platform software (K223578) | Etiometry, Inc. | 2023-07-07 |
| T3 Platform Software (K213230) | Etiometry, Inc. | 2022-06-22 |
| CipherOx CRI Tablet (K213255) | Flashback Technologies, Inc. | 2022-06-17 |
| CipherOx CRI M1 (K173929) | Flashback Technologies, Inc. | 2018-07-24 |
| CipherOx CRI Tablet (DEN160020) | Flashback Technologies, Inc. | 2016-12-21 |
Recalls involving this device
No recalls on record reference this clearance.