Home / 510(k) Clearances / K254066

510(k) K254066

Etiometry Platform by Etiometry, Inc. — Product Code PPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2026
Date Received
December 18, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Cardiovascular Status Indicator
Device Class
Class II
Regulation Number
870.2200
Review Panel
CV
Submission Type

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 clearances by Etiometry, Inc.

  • K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) (February 12, 2025)
  • K223578 — T3 Platform software (July 7, 2023)
  • K213423 — T3 Platform software (January 6, 2023)
  • K213230 — T3 Platform Software (June 22, 2022)
  • K202306 — T3 Platform software (November 25, 2020)
  • K190273 — T3 Platform software (December 8, 2019)
  • K163065 — T3 Software (May 26, 2017)
  • K152258 — T3 Software (March 31, 2016)
  • K151715 — T3 Software (October 29, 2015)
  • K142732 — T3 Software (March 4, 2015)

Other clearances for product code PPW

  • K252204 — prolaio eVO2peak Module (Version 1.0) (December 16, 2025)
  • K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) (February 12, 2025)
  • K223578 — T3 Platform software (July 7, 2023)
  • K213230 — T3 Platform Software (June 22, 2022)
  • K213255 — CipherOx CRI Tablet (June 17, 2022)
  • K173929 — CipherOx CRI M1 (July 24, 2018)
  • DEN160020 — CipherOx CRI Tablet (December 21, 2016)