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..
FDA 510(k) Cleared Adjunctive Cardiovascular Status Indicator Devices (Product Code PPW)
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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
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 →