Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- OZWIngestible Event Marker2Product Code
- K251088Otsuka Digital Feedback Device2Cleared 510(K)
- K223463Otsuka Digital Feedback Device-RW2Cleared 510(K)
- K183052ID-Cap System2Cleared 510(K)
- K150494Proteus Digital Health Feedback Device2Cleared 510(K)
- K133263PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)2Cleared 510(K)
- K131524PROTEUS PATCH INCLUDING INGESTIBLE SENSOR2Cleared 510(K)
- K131009PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)2Cleared 510(K)
- DEN120011PROTEUS INGESTION CONFINMATION SYSTEMS2Cleared 510(K)
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Otsuka Digital Feedback Device
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K251088
- 510(k) Type
- Traditional
- Applicant
- Otsuka America Pharmaceutical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/30/2025
- Days to Decision
- 82 days
- Submission Type
- Summary