OZW · Ingestible Event Marker
General Hospital · 21 CFR 880.6305 · Class 2
Overview
| Product Code | OZW |
|---|---|
| Device Name | Ingestible Event Marker |
| Regulation | 21 CFR 880.6305 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the Proteus Personal Monitor including Ingestion Event Marker is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | Jun 30, 2025 | SESE |
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | Aug 11, 2023 | SESE |
| K183052 | ID-Cap System | Etectrx, Inc. | Dec 6, 2019 | SESE |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | Jun 27, 2015 | SESE |
| K133263 | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | Feb 7, 2014 | SESE |
| K131524 | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | Proteus Digital Health, Inc. | Jun 23, 2013 | SESE |
| K131009 | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | May 7, 2013 | SESE |
| DEN120011 | PROTEUS INGESTION CONFINMATION SYSTEMS | Proteus Biomedical, Inc. | Jul 10, 2012 | DENG |
Top Applicants
- Proteus Digital Health, Inc. — 4 clearances
- Otsuka America Pharmaceutical, Inc. — 2 clearances
- Etectrx, Inc. — 1 clearance
- Proteus Biomedical, Inc. — 1 clearance
