OZW · Class II · 21 CFR 880.6305

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 Proteus Digital Health, Inc., Otsuka America Pharmaceutical, Inc. and Proteus Biomedical, Inc..

8
Total
7
Cleared
136d
Avg days
2012
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 82d recently vs 144d historically

FDA 510(k) Cleared Ingestible Event Marker Devices (Product Code OZW)

8 devices
1–8 of 8
Cleared Jun 30, 2025
Otsuka Digital Feedback Device
K251088
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 82d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Dec 06, 2019
ID-Cap System
K183052
Etectrx, Inc.
Cardiovascular · 399d
Cleared Jun 27, 2015
Proteus Digital Health Feedback Device
K150494
Proteus Digital Health, Inc.
Gastroenterology & Urology · 122d
Cleared Feb 07, 2014
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K133263
Proteus Digital Health, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 23, 2013
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K131524
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared May 07, 2013
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
K131009
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Not Cleared Jul 10, 2012
PROTEUS INGESTION CONFINMATION SYSTEMS
DEN120011
Proteus Biomedical, Inc.
Gastroenterology & Urology · 60d

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 510(k) Review Time - OZW Product Code

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 Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →