FDA Product Code OZW: Ingestible Event Marker
To Provide Confirmation Of An Event Co-ingested Or Coincident With The Ingestible Component Of The Device. The Wearable Component Of The Device Incorporates Wireless Communication To Display The Event And Other Information On A General Computing Device
Leading manufacturers include Otsuka America Pharmaceutical, Inc..
FDA 510(k) Cleared Ingestible Event Marker Devices (Product Code OZW)
About Product Code OZW - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code OZW since 2012, with 7 receiving FDA clearance (average review time: 136 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OZW have taken an average of 82 days to reach a decision - down from 144 days historically, suggesting improved FDA processing for this classification.
OZW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →