FDA Product Code PPW: Adjunctive Cardiovascular Status Indicator
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.
Leading manufacturers include Etiometry, Inc., Flashback Technologies, Inc. and Prolaio, Inc..
8
Total
7
Cleared
211d
Avg days
2016
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
175d
recently vs 233d historically
FDA 510(k) Cleared Adjunctive Cardiovascular Status Indicator Devices (Product Code PPW)
8 devices
Cleared
Apr 03, 2026
Etiometry Platform
Etiometry, Inc.
Cardiovascular
106d
Cleared
Dec 16, 2025
prolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
Cardiovascular
155d
Cleared
Feb 12, 2025
Etiometry Platform (DAV 5.4 RAE 9.2)
Etiometry, Inc.
Cardiovascular
264d
Cleared
Jul 07, 2023
T3 Platform software
Etiometry, Inc.
Cardiovascular
219d
Cleared
Jun 22, 2022
T3 Platform Software
Etiometry, Inc.
Cardiovascular
266d
Cleared
Jun 17, 2022
CipherOx CRI Tablet
Flashback Technologies, Inc.
Cardiovascular
260d
Cleared
Jul 24, 2018
CipherOx CRI M1
Flashback Technologies, Inc.
Cardiovascular
210d
About Product Code PPW - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PPW since 2016, with 7 receiving FDA clearance (average review time: 211 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PPW Product Code
Recent submissions under PPW have taken an average of 175 days to reach a decision - down from 233 days historically, suggesting improved FDA processing for this classification.
PPW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →