OZW — Ingestible Event Marker Class II
FDA product code OZW covers "Ingestible Event Marker", a Class II medical device regulated under 21 CFR 880.6305. Submissions are reviewed by the General Hospital panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZW
- Device Class
- Class II
- Regulation Number
- 880.6305
- Submission Type
- Review Panel
- CV
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251088 | Otsuka America Pharmaceutical | Otsuka Digital Feedback Device | Jun 30, 2025 |
| K223463 | Otsuka America Pharmaceutical | Otsuka Digital Feedback Device-RW | Aug 11, 2023 |
| K183052 | Etectrx | ID-Cap System | Dec 6, 2019 |
| K150494 | Proteus Digital Health | Proteus Digital Health Feedback Device | Jun 27, 2015 |
| K133263 | Proteus Digital Health | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | Feb 7, 2014 |
| K131524 | Proteus Digital Health | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | Jun 23, 2013 |
| K131009 | Proteus Digital Health | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | May 7, 2013 |
| DEN120011 | Proteus Biomedical | PROTEUS INGESTION CONFINMATION SYSTEMS | Jul 10, 2012 |