OZW
8 FDA 510(k) clearances · Product code
107 daysmedian time to decision
399 days90th percentile
8clearances measured
FDA profile
- Official device name
- Ingestible Event Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6305
- Medical specialty
- General Hospital
- FDA 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Otsuka Digital Feedback Device (K251088) | Otsuka America Pharmaceutical, Inc. | 2025-06-30 |
| Otsuka Digital Feedback Device-RW (K223463) | Otsuka America Pharmaceutical, Inc. | 2023-08-11 |
| ID-Cap System (K183052) | Etectrx, Inc. | 2019-12-06 |
| Proteus Digital Health Feedback Device (K150494) | Proteus Digital Health, Inc. | 2015-06-27 |
| PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (K133263) | Proteus Digital Health, Inc. | 2014-02-07 |
| PROTEUS PATCH INCLUDING INGESTIBLE SENSOR (K131524) | Proteus Digital Health, Inc. | 2013-06-23 |
| PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (K131009) | Proteus Digital Health, Inc. | 2013-05-07 |
| PROTEUS INGESTION CONFINMATION SYSTEMS (DEN120011) | Proteus Biomedical, Inc. | 2012-07-10 |
Track OZW automatically
Every clearance here is in the API, with alerts when new ones post.