K251088 is an FDA 510(k) clearance for the Otsuka Digital Feedback Device. This device is classified as a Ingestible Event Marker (Class II - Special Controls, product code OZW).
Submitted by Otsuka America Pharmaceutical, Inc. (Hayward, US). The FDA issued a Cleared decision on June 30, 2025, 82 days after receiving the submission on April 9, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.6305. 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.
| 510(k) Number | K251088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2025 |
| Decision Date | June 30, 2025 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OZW - Ingestible Event Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6305 |
| 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 |