Otsuka Digital Feedback Device
FDA 510(k) clearance K251088 · decided 2025-06-30
Clearance details
- K-number
- K251088
- Device name
- Otsuka Digital Feedback Device
- Applicant
- Otsuka America Pharmaceutical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-09
- Decision date
- 2025-06-30
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- OZW
- Device class
- 2
- Regulation number
- 880.6305
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.