Etiometry Platform (DAV 5.4 RAE 9.2)
FDA 510(k) clearance K241479 · decided 2025-02-12
Clearance details
- K-number
- K241479
- Device name
- Etiometry Platform (DAV 5.4 RAE 9.2)
- Applicant
- Etiometry, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-24
- Decision date
- 2025-02-12
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- PPW
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Etiometry
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Etiometry Platform (K254066) | Etiometry, Inc. | 2026-04-03 |
| prolaio eVO2peak Module (Version 1.0) (K252204) | Prolaio, Inc. | 2025-12-16 |
| 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.